Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
Study Drug: TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab Dosing Details: Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle). Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab by intravenous infusion once every 14 days
Georgetown University
Washington D.C., District of Columbia, United States
Length of Progression-Free Survival
Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.
Time frame: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
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