RECRUITING

Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer

Conditions

Colon Cancer Rectal Cancer Sequential Combined TAS-102 Oxaliplatin Irinotecan Late-Line Metastatic Colorectal Cancer Bevacizumab

Quick Navigation

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 study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)

Official Title

Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer

Quick Facts

Study Start:2023-05-17

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05806931

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
* Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate. * Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease. * Progression of disease must be documented on the most recent scan. * Presence of measurable disease * RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined). * Age 18 years or older. * ECOG performance status 0-1. * Life expectancy of at least three months. * Participants with adequate organ function: 1. Absolute neutrophil count (ANC) \> 1.5 x 109/L 2. Hemoglobin \> 9 g/dL 3. Platelets (PLT) \> 70 x 109/L 4. AST/ALT \< 5 x ULN 5. Albumin within normal limits for institution * Women who are nursing and discontinue nursing prior to enrollment in the program. * Ability to take oral medication (i.e., no feeding tube). * Participant able and willing to comply with study procedures as per protocol. * Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.	* Participants who have previously received TAS-102. * Grade 3 or higher peripheral neuropathy (functional impairment). * Inability to tolerate irinotecan previously (due to uncontrolled diarrhea) * There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is \>1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab. * Symptomatic CNS metastases requiring treatment. * Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer). * Pregnancy or breast feeding. * Current therapy with other investigational agents. * Active infection with body temperature \> 38°C due to infection. * Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration). * Any anticancer therapy within prior two weeks of first dose of study drug. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102. * Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks. * Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication. * Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.
* Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.
* Progression of disease must be documented on the most recent scan.
* Presence of measurable disease
* RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).
* Age 18 years or older.
* ECOG performance status 0-1.
* Life expectancy of at least three months.
* Participants with adequate organ function:
1. Absolute neutrophil count (ANC) \> 1.5 x 109/L
2. Hemoglobin \> 9 g/dL
3. Platelets (PLT) \> 70 x 109/L
4. AST/ALT \< 5 x ULN
5. Albumin within normal limits for institution
* Women who are nursing and discontinue nursing prior to enrollment in the program.
* Ability to take oral medication (i.e., no feeding tube).
* Participant able and willing to comply with study procedures as per protocol.
* Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.

* Participants who have previously received TAS-102.
* Grade 3 or higher peripheral neuropathy (functional impairment).
* Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)
* There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is \>1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab.
* Symptomatic CNS metastases requiring treatment.
* Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer).
* Pregnancy or breast feeding.
* Current therapy with other investigational agents.
* Active infection with body temperature \> 38°C due to infection.
* Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration).
* Any anticancer therapy within prior two weeks of first dose of study drug.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102.
* Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks.
* Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.
* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Contacts and Locations

Study Contact

Howard S. Hochster, MD

CONTACT

732-253-5618

howard.hochster@rutgers.edu

Principal Investigator

Howard S. Hochster, MD

PRINCIPAL_INVESTIGATOR

Cancer Institute of New Jersey Rutgers

Study Locations (Sites)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202

United States

RWJBarnabas Health Jersey City Medical Center

Jersey City, New Jersey, 07302

United States

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701

United States

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

Livingston, New Jersey, 07039

United States

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, 08873

United States

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Howard S. Hochster, MD, PRINCIPAL_INVESTIGATOR, Cancer Institute of New Jersey Rutgers

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 Date2023-05-17

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2023-05-17

Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

Sequential Combined TAS-102
Oxaliplatin
Irinotecan
Late-Line Metastatic Colorectal Cancer
Bevacizumab

Additional Relevant MeSH Terms

Colon Cancer
Rectal Cancer