A Phase 2 study of concurrent combination therapy of TFTD (TAS-102) and bevacizumab in patients of more than 70 years of age with unresectable, advanced/recurrent colorectal cancer (KSCC 1602)
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000025241
- Lead Sponsor
- Kyushu Study group of Clinical Cancer
- Brief Summary
Primary Endpoint PFS was 8.0 months (80% CI, 6.7-11.2). Secondary Endpoints ORR (CR+PR) was 40.5% (95% confidence interval [CI], 24.8-57.9) median OS was no t reached The AEs which were frequent as grade 3 o r 4 were leucopenia (71.8 % ), neutropenia (48.7 % ), anorexia (12.8 % ), febrile neutropenia (10.3 % ). Major non-hematological AEs were hypertension 8/39 (20.5% ) and Fatigue 4/39 (10.3% ).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 39
Not provided
1) Serious drug-induced hypersensitivity (especially, platinum formulation, 5-FU, TFTD) 2) Patients received palliative operation (it is eligible at 28 days after the operation with the intestinal anastomosis, at 14 days after colostomy) 3) Patients with active infectious disorder 4) Patients with uncontrollable hypertension. 5) Patients with under treatment by continuous use of insulin or with complication of uncontrollable diabetes mellitus 6) Patients with cardiac disorder such as congestive heart failure, angina to need medication, transmural myocardial infarction definitely observed in ECG, clinically apparent valvular disease, symptomatic coronary disease, uncontrollable arrhythmia, anamnesis of myocardial infarction that developed within the past 12 months. 7) Patients with severe pulmonary disorder such as interstitial pneumonia, pulmonary fibrosis, severe emphysema. 8) Patients with mental disorder or with anamnesis of central nervous system disorder. 9) Patients who have the fresh bleeding from gastrointestinal tract needing a transfusion repeatedly. 10) Patients who are receiving anticoagulant. 11) Patients with watery stool (>=Grade2) 12) Active double cancer. Synchronous double cancer and metachronous double cancer within a disease-free interval of 5 years. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been cured by local treatment are not classified as active multiple cancers. 13) Male patients with hope of pregnancy of his partner. 14) Patients with cirrhosis or active hepatitis. 15) Any other patients who are regarded as unsuitable for this study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method