Spots Global Cancer Trial Database for TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
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Trial Identification
Brief Title: TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
Official Title: A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pre-Treated Metastatic Colorectal Cancer (TABAsCO)
Study ID: NCT04109924
Conditions
Study Description
Brief Summary: This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, 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. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.
Detailed Description: PRIMARY OBJECTIVE: I. Determine the median progression free survival (PFS) benefit of leucovorin calcium, 5-fluorouracil, and irinotecan (FOLFIRI) naive patients treated with trifluridine and tipiracil hydrochloride (TAS-102) + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. SECONDARY OBJECTIVE: I. Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile. OUTLINE: Patients receive irinotecan intravenously (IV) over 90 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moffitt Cancer Center, Tampa, Florida, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: Christos Fountzilas, MD
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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