What is TAS-102 studying for metastatic colorectal cancer?

TAS-102 is being studied in combination with oxaliplatin, irinotecan, and bevacizumab to see how well it controls disease and delays progression in late-stage colorectal cancer. The research focuses on patients whose cancer has advanced after standard treatments. Rutgers University is leading this clinical trial to evaluate this new treatment approach.

Who may be eligible for this metastatic colorectal cancer clinical trial?

Adults 18 years and older diagnosed with stage IV colon cancer that has progressed after standard chemotherapy and antibody therapy may be eligible. Participants must have measurable disease, good performance status, and adequate organ function. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs not covered by the study.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05806931

Study of Sequential TAS-102 with Oxaliplatin Alternating with TAS-102 and Irinotecan Combined with Bevacizumab for Treatment of Advanced Metastatic Colorectal Cancer

Led by Rutgers, The State University of New Jersey · Updated on 2026-03-18

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a combination treatment involving TAS-102 with oxaliplatin alternating with TAS-102 and irinotecan, along with bevacizumab, for late-stage metastatic colorectal cancer mCRC that has progressed after standard therapies. This phase II trial aims to assess the disease control rate and time to progression using this sequential approach. Participants will take TAS-102 orally twice daily on days 1 to 5 of each 14-day treatment cycle. Oxaliplatin infusion is given on day one of one cycle, alternating with irinotecan infusion on day one of the next cycle. Bevacizumab is also given alongside these treatments. Treatment continues until disease progression is seen on scans or adverse effects require stopping. During the study, participants will have regular assessments including scans to monitor disease progression. Researchers will measure outcomes like disease control rate, progression-free survival, overall survival, response rate, and response duration for up to 100 months. Safety and treatment tolerability will be closely monitored, and participants will be evaluated regularly to track their health and response to therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed stage IV colon cancer that progressed after standard therapy including 5-FU, irinotecan, oxaliplatin, and antibody therapy
Prior adjuvant chemotherapy with recurrence within six months counts as one chemotherapy regimen
Documented disease progression on recent scans
Presence of measurable disease
RAS mutation and MMR status determined or available for testing
Age 18 years or older
ECOG performance status 0-1
Life expectancy of at least three months
Adequate organ function including ANC > 1.5 x 10^9/L, hemoglobin > 9 g/dL, platelets > 70 x 10^9/L, AST/ALT < 5 x ULN, and normal albumin
Women who have stopped nursing prior to enrollment
Ability to take oral medication without feeding tube
Willingness and ability to comply with study procedures and provide informed consent

You will not qualify if you...

Previous treatment with TAS-102
Grade 3 or higher peripheral neuropathy causing functional impairment
Inability to tolerate irinotecan due to uncontrolled diarrhea
Symptomatic CNS metastases requiring treatment
Other active cancer within last three years except certain skin or in situ cancers
Pregnancy or breastfeeding
Current treatment with other investigational agents
Active infection with fever over 38°C
Major surgery within prior four weeks without full healing
Anticancer therapy within two weeks of first study dose
Allergic reactions to compounds similar to TAS-102
Participation in another clinical trial or investigational agent within four weeks
Grade 3 or higher hypersensitivity to oxaliplatin or irinotecan, or lower grade oxaliplatin hypersensitivity not controlled by pre-medication
Unresolved toxicity of grade 2 or higher from prior therapies except certain conditions like anemia or alopecia

Research Team

Howard S. Hochster, MD

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Study of Sequential TAS-102 with Oxaliplatin Alternating with TAS-102 and Irinotecan Combined with Bevacizumab for Treatment of Advanced Metastatic Colorectal Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria