Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
- Registration Number
- NCT02654639
- Lead Sponsor
- Georgetown University
- Brief Summary
Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAS-102 and Bevacizumab TAS-102 Oral TAS-102 and intravenous Bevacizumab. TAS-102 and Bevacizumab Bevacizumab Oral TAS-102 and intravenous Bevacizumab.
- Primary Outcome Measures
Name Time Method Length of Progression-Free Survival From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Georgetown University
🇺🇸Washington, District of Columbia, United States