TAS-102 + Oxaliplatin for Colon Cancer

Recruiting at5 trial locations

Overseen by Howard S. Hochster

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, 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.

Research Team

Howard S. Hochster

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for adults with stage IV colon cancer that's worsened after standard treatment. They should have had a reaction to previous treatments, measurable disease, specific genetic features (RAS mutation and MMR status), good physical function, and acceptable blood counts. They must not be pregnant or breastfeeding, have no major recent surgery or active infections, and can't have used TAS-102 before.

Inclusion Criteria

My stage IV colon cancer has worsened after standard treatment.

I stopped my cancer treatment due to severe side effects.

Progression of disease must be documented on the most recent scan

Exclusion Criteria

Pregnancy or breast feeding

I haven't had cancer treatment in the last 3 weeks.

You have had allergic reactions to similar medications like TAS-102 in the past.

Treatment Details

Interventions

• Oxaliplatin (Alkylating agents)
• TAS-102 (Anti-metabolites)

Trial Overview The study tests how well TAS-102 combined with oxaliplatin works in treating advanced colon cancer. It's a phase II trial where these chemotherapy drugs are given to see if they can stop cancer cells from growing by killing them or preventing their spread.

Participant Groups

Group I: Treatment (TAS-102, oxaliplatin) Experimental Treatment 2 Interventions

Patients receive TAS-102 PO BID on days 1-5 and oxaliplatin IV over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Oxaliplatin is already approved in Canada, Japan, Switzerland, China for the following indications:

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School