RECRUITING

Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer

Conditions

Metastatic Colorectal Carcinoma Metastatic Malignant Neoplasm in the Peritoneum Stage IV Colorectal Cancer AJCC v8

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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 I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.

Official Title

A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients With Colorectal Cancer With Isolated Peritoneal Metastasis

Quick Facts

Study Start:2024-06-30

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06269978

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
* Age \>= 18 years * Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician * Primary colorectal cancer may either be left in place or have been resected prior to study enrollment * Patients must not have not received colorectal cancer directed systemic therapy in the metastatic setting. Prior adjuvant chemotherapy is permitted, provided it has been \>= 6 months since receiving the last dose of adjuvant chemotherapy at the time of study enrollment * Expected to have PCI of \> 20 in the opinion of the treating physician based on imaging * Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment * Absolute neutrophil count (ANC) ≥ 1,500 /mcL * Platelets ≥ 100,000 / mcL * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) * Creatinine clearance should be calculated per institutional standard * Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \> 1.5 ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Both values must be in the specified range * Albumin \>= 2.5 g/dL * International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures * Anticipated life expectancy of ≥ 6 months * Willing to comply with study procedures * Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication * For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment * Be willing and able to understand and sign the written informed consent document * Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial * Be willing to provide peripheral blood samples for correlative studies	* Patients who are receiving any other investigational drugs * Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging * Patients with \>= grade 2 peripheral neuropathy * Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements * Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration * Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \[PCR\]) hepatitis B or C * Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Pregnancy or breastfeeding * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician

Inclusion Criteria

Exclusion Criteria

* Age \>= 18 years
* Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician
* Primary colorectal cancer may either be left in place or have been resected prior to study enrollment
* Patients must not have not received colorectal cancer directed systemic therapy in the metastatic setting. Prior adjuvant chemotherapy is permitted, provided it has been \>= 6 months since receiving the last dose of adjuvant chemotherapy at the time of study enrollment
* Expected to have PCI of \> 20 in the opinion of the treating physician based on imaging
* Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment
* Absolute neutrophil count (ANC) ≥ 1,500 /mcL
* Platelets ≥ 100,000 / mcL
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
* Creatinine clearance should be calculated per institutional standard
* Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \> 1.5 ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Both values must be in the specified range
* Albumin \>= 2.5 g/dL
* International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
* Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures
* Anticipated life expectancy of ≥ 6 months
* Willing to comply with study procedures
* Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication
* For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment
* Be willing and able to understand and sign the written informed consent document
* Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial
* Be willing to provide peripheral blood samples for correlative studies

* Patients who are receiving any other investigational drugs
* Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging
* Patients with \>= grade 2 peripheral neuropathy
* Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements
* Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration
* Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \[PCR\]) hepatitis B or C
* Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
* Pregnancy or breastfeeding
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Arjun Mittra, MD

PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Arjun Mittra

Arjun Mittra, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

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 Date2024-06-30

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-06-30

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Colorectal Carcinoma
Metastatic Malignant Neoplasm in the Peritoneum
Stage IV Colorectal Cancer AJCC v8