SUSPENDED

Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial

Conditions

Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has PTEN and AKT genetic changes. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with PTEN and AKT genetic changes could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth.

Official Title

Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

Quick Facts

Study Start:2023-09-22

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05554380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-S3 based on the presence of an actionable mutation as defined in EAY191 * GENERAL COMBOMATCH EAY191 REGISTRATION	* Participants must not have an activating KRAS, NRAS, HRAS, or BRAF mutation (a single nucleotide variant, insertion, or deletion) as determined by the ComboMATCH screening assessment * Participants must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191) * Participants must have a histologically confirmed non-breast solid malignancy * Participants must have locally advanced, unresectable, or metastatic disease in the opinion of the treating investigator * Participants must have measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration * Participants with known brain metastases must have a CT/MRI scan to evaluate for central nervous system (CNS) disease and show no evidence of progression within 42 days prior to registration * Participants must have completed any CNS-directed therapy and/or local therapy for spinal cord compression at least 28 days prior to registration * Participants must not have spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days prior to registration, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to registration * Participants must not have leptomeningeal disease * Participants must have progressed on or within 6 months of taxane-based therapy in the neoadjuvant/adjuvant or metastatic setting prior to registration * Participants must not have received any prior AKT inhibitor (e.g., capivasertib or ipatasertib); prior PI3K/mTOR inhibitor is acceptable * Participants must not have received cancer-directed therapy prior for at least 14 days prior to initiation of treatment on study * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic, radiation, or hormonal therapy for cancer treatment while receiving treatment on this study * Participants must be \>= 18 years of age * Participants must be able to swallow oral medications whole * Participants must have a pre-study history and physical exam done within 28 days prior to registration * Participants must have a Zubrod performance status of 0-2 within 28 days prior to registration * Participants must have adverse events resolved =\< grade 1 related to any prior therapy, except alopecia within 14 days prior to registration * Participants with neuropathy must have resolved to \< grade 2 within 14 days prior to registration * Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration) * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration) * Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration) * Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration) * Aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration) * Participants must have adequate cardiac function, class IIB (2B) or better. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification * Participants must have a measured OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn within 28 days prior to registration * Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test results obtained within 6 months prior to registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration * Participants must have an electrocardiography (ECG) performed (if clinically indicated with a corrected QTc interval of =\< 470 msec) within 28 days prior to registration * Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib and/or paclitaxel * Participants must not have an active small/large bowel inflammation such as ulcerative colitis or Crohn's disease * Participants must not have grade 2 or higher uncontrolled intercurrent illness * NOTE: To receive an agent, participant must not have any uncontrolled intercurrent illness requiring antibiotic/antiviral/antifungal therapy or interventional procedures. Participants with infections unlikely to be resolved within 2 weeks following registration should not be considered for the trial * Participants must not have a known grade 2 or higher uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia * Participants must not have any of the following: * Cirrhosis at a level of Child-Pugh B (or worse), * Cirrhosis (any degree) and a history of hepatic encephalopathy, or * Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Participants must not be receiving any medications or substances that are inhibitors or inducers of CYP3A. Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug is prohibited. * NOTE: Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. The participant wallet card should be presented to the participant * Participants must not have baseline fasting glucose (after 8-hour fast) \> 160 mg/dL (8.9 mmol/L) within 28 days prior to registration * Participants with known diabetes mellitus must not require insulin therapy or have a baseline fasting glucose \>150 mg/dL (8.3 mmol/L) or high glycosylated hemoglobin (Hb)A1c, (\>= 8.0%), suggesting poorly controlled diabetes * Participants who are on a stable dose of oral diabetes medication \>= 2 weeks prior to initiation of study drug treatment are eligible for enrollment * Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) must not have a potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not have lung disease requiring active systemic therapy or placing participants at increased risk of toxicity related to study-directed therapy including, but not limited to pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia) * Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is of "reproductive potential". In addition to routine contraceptive methods, "effective contraception" also includes surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must not have psychiatric illness/social situations that would limit compliance with study requirements

Inclusion Criteria

Exclusion Criteria

* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-S3 based on the presence of an actionable mutation as defined in EAY191
* GENERAL COMBOMATCH EAY191 REGISTRATION

* Participants must not have an activating KRAS, NRAS, HRAS, or BRAF mutation (a single nucleotide variant, insertion, or deletion) as determined by the ComboMATCH screening assessment
* Participants must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
* Participants must have a histologically confirmed non-breast solid malignancy
* Participants must have locally advanced, unresectable, or metastatic disease in the opinion of the treating investigator
* Participants must have measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
* Participants with known brain metastases must have a CT/MRI scan to evaluate for central nervous system (CNS) disease and show no evidence of progression within 42 days prior to registration
* Participants must have completed any CNS-directed therapy and/or local therapy for spinal cord compression at least 28 days prior to registration
* Participants must not have spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days prior to registration, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to registration
* Participants must not have leptomeningeal disease
* Participants must have progressed on or within 6 months of taxane-based therapy in the neoadjuvant/adjuvant or metastatic setting prior to registration
* Participants must not have received any prior AKT inhibitor (e.g., capivasertib or ipatasertib); prior PI3K/mTOR inhibitor is acceptable
* Participants must not have received cancer-directed therapy prior for at least 14 days prior to initiation of treatment on study
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic, radiation, or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must be \>= 18 years of age
* Participants must be able to swallow oral medications whole
* Participants must have a pre-study history and physical exam done within 28 days prior to registration
* Participants must have a Zubrod performance status of 0-2 within 28 days prior to registration
* Participants must have adverse events resolved =\< grade 1 related to any prior therapy, except alopecia within 14 days prior to registration
* Participants with neuropathy must have resolved to \< grade 2 within 14 days prior to registration
* Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
* Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
* Aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
* Participants must have adequate cardiac function, class IIB (2B) or better. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification
* Participants must have a measured OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn within 28 days prior to registration
* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
* Participants must have an electrocardiography (ECG) performed (if clinically indicated with a corrected QTc interval of =\< 470 msec) within 28 days prior to registration
* Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib and/or paclitaxel
* Participants must not have an active small/large bowel inflammation such as ulcerative colitis or Crohn's disease
* Participants must not have grade 2 or higher uncontrolled intercurrent illness
* NOTE: To receive an agent, participant must not have any uncontrolled intercurrent illness requiring antibiotic/antiviral/antifungal therapy or interventional procedures. Participants with infections unlikely to be resolved within 2 weeks following registration should not be considered for the trial
* Participants must not have a known grade 2 or higher uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
* Participants must not have any of the following:
* Cirrhosis at a level of Child-Pugh B (or worse),
* Cirrhosis (any degree) and a history of hepatic encephalopathy, or
* Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
* Participants must not be receiving any medications or substances that are inhibitors or inducers of CYP3A. Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug is prohibited.
* NOTE: Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. The participant wallet card should be presented to the participant
* Participants must not have baseline fasting glucose (after 8-hour fast) \> 160 mg/dL (8.9 mmol/L) within 28 days prior to registration
* Participants with known diabetes mellitus must not require insulin therapy or have a baseline fasting glucose \>150 mg/dL (8.3 mmol/L) or high glycosylated hemoglobin (Hb)A1c, (\>= 8.0%), suggesting poorly controlled diabetes
* Participants who are on a stable dose of oral diabetes medication \>= 2 weeks prior to initiation of study drug treatment are eligible for enrollment
* Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) must not have a potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have lung disease requiring active systemic therapy or placing participants at increased risk of toxicity related to study-directed therapy including, but not limited to pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is of "reproductive potential". In addition to routine contraceptive methods, "effective contraception" also includes surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must not have psychiatric illness/social situations that would limit compliance with study requirements

Contacts and Locations

Principal Investigator

Reva K Basho

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688

United States

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

United States

Kingman Regional Medical Center

Kingman, Arizona, 86401

United States

PCR Oncology

Arroyo Grande, California, 93420

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, 90025

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Saint Joseph Hospital - Orange

Orange, California, 92868

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

Saint John's Cancer Institute

Santa Monica, California, 90404

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Harold Alfond Center for Cancer Care

Augusta, Maine, 04330

United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412

United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124

United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336

United States

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

United States

Essentia Health Cancer Center

Duluth, Minnesota, 55805

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Essentia Health Sandstone

Sandstone, Minnesota, 55072

United States

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122

United States

Strecker Cancer Center-Belpre

Belpre, Ohio, 45714

United States

Aultman Health Foundation

Canton, Ohio, 44710

United States

Adena Regional Medical Center

Chillicothe, Ohio, 45601

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Mount Carmel East Hospital

Columbus, Ohio, 43213

United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, 43214

United States

Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Grant Medical Center

Columbus, Ohio, 43215

United States

The Mark H Zangmeister Center

Columbus, Ohio, 43219

United States

Doctors Hospital

Columbus, Ohio, 43228

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, 43015

United States

Grady Memorial Hospital

Delaware, Ohio, 43015

United States

Columbus Oncology and Hematology Associates

Dublin, Ohio, 43016

United States

Dublin Methodist Hospital

Dublin, Ohio, 43016

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Fairfield Medical Center

Lancaster, Ohio, 43130

United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903

United States

OhioHealth Marion General Hospital

Marion, Ohio, 43302

United States

Memorial Hospital

Marysville, Ohio, 43040

United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060

United States

Knox Community Hospital

Mount Vernon, Ohio, 43050

United States

Licking Memorial Hospital

Newark, Ohio, 43055

United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, 43551

United States

Southern Ohio Medical Center

Portsmouth, Ohio, 45662

United States

Springfield Regional Cancer Center

Springfield, Ohio, 45504

United States

Springfield Regional Medical Center

Springfield, Ohio, 45504

United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, 43623

United States

Saint Ann's Hospital

Westerville, Ohio, 43081

United States

OhioHealth Westerville Medical Campus/Westerville Cancer Center

Westerville, Ohio, 43082

United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

Riddle Memorial Hospital

Media, Pennsylvania, 19063

United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

Women and Infants Hospital

Providence, Rhode Island, 02905

United States

Rapid City Regional Hospital

Rapid City, South Dakota, 57701

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Virginia Cancer Institute

Richmond, Virginia, 23229

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24033

United States

VCU Community Memorial Health Center

South Hill, Virginia, 23970

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Valley Medical Center

Renton, Washington, 98055

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902

United States

Duluth Clinic Ashland

Ashland, Wisconsin, 54806

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Reva K Basho, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-09-22

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm