Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer
Rutgers, The State University of New Jersey
Summary
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)
Description
This phase II trial will evaluate efficacy of TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC. Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 recurren…
Interventions
- DrugTAS-102, oxaliplatin, irinotecan with bevacizumab
Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events. TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC.
Locations (9)
- Trinitas Hospital and Comprehensive Cancer CenterElizabeth, New Jersey
- RWJBarnabas Health Jersey City Medical CenterJersey City, New Jersey
- RWJBarnabas Health - Monmouth Medical Center Southern CampusLakewood, New Jersey
- Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)Livingston, New Jersey
- RWJBarnabas Health - Monmouth Medical CenterLong Branch, New Jersey
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey