Phase II trial of FOLFIRI plus Bevacizumab in second-line therapy after progression on bevacizumab with oxaliplatine-based chemotherapy in patients with metastatic colorectal cancer whose KRAS status are investigated.
- Conditions
- Recurrent or metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000004219
- Lead Sponsor
- Hyogo Cancer Center, Dept. of Gastrointestinal and Hepatobiliary Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1.clinical or radiological evidence of CNS metastases 2.current or previous (at least once within the last 1 year/ twice or more) history of arterial thromboembolism such as cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to enrollment/ fine-needle aspiration cytology within 7 days prior to enrollment 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.evidence of bleeding diathesis, coagulopathy or abnormal coagulation factor (PT-INR>=1.5 within 14 days prior to enrollment) 7.current or recent (within 10 days prior to enrollment) ongoing treatment with anticoagulants for therapeutic purposes 8.ongoing treatment with aspirin (>= 325 mg/day), nonsteroid anti-inflammatory drug or adrenocortical steroid 9.clinically significant (i.e. active) cardiovascular disease (NCI-CTCAE grade 2 or worse), or past or current history (at least once within the last 1 year/ twice or more) of myocardial infarction 10.renal failure need to treat 11.serious complication (uncontrolled ulcer, hypertension, diabetes mellitus, infection, diarrhea,etc) 12.uncontrolled pleural effusion and/or ascites 13.past or current history (within the last 5 years) of malignant disease, except for the early cancer healed clearly 14.interstitial lung disease, or pulmonary fibrosis 15.history of organ transplantation 16.pregnancy, lactation and positive serum pregnancy test/no birth-control 17.serious drug hypersensitivity or history of drug allergy of 5-FU, l-LV and/or irinotecan 18.history of adverse reaction to fluorouracil in which DPD deficiency is suspected 19.any other cases who are regarded as inadequate for trial enrollment by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line overall response rate, safety, resection rate of metastatic lesion, time to treatment-failure, progression free survival, overall survival, overall survival from first- line in KRAS wild-type and mutant population, respectively