Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab
- Conditions
- advanced colorectal cancer
- Registration Number
- JPRN-UMIN000007065
- Lead Sponsor
- Toyama Prefectural Central Hospital Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Not provided
(1)Previously irinotecan treatment (2)Administering transfusion/hematopoietic factor or antithrombotic drug within 14 days (3)Serious renal dysfunction (4)Serious drug hypersensitivity or a history of drug allergy (5)Active concomitant malignancy (6)Uncontrolled infection (7)Symptomatic or asymptomatic but treated heart disease (8)History of thrombosis,interstitial pneumonitis,pulmonary fibrosis or high-grade pulmonary emphysema (9)Fresh hemorrhage from digestive tube,intestines tube paralysis,intestinal obstruction and peptic ulcer (10)Pleural effusion,peritoneal fluid and pericardial fluid (11)Symptomatic brain metastasis (12)History of mental disturbances or cerebrovascular accident (13)high blood pressure and diabetic that cannot be controlled (14)Uncontrolled diarrhea (15)Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study (16)Traumatic fracture of unrecovery (17)Bleeding tendency and anti-platelets therapy (18)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers (19)Need to treatment with atazanavir sulfate (20)Paralyzed bowel (21)Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival Response Rate Progression free survival according to K-ras status Overall survival according to K-ras status Frequency of adverse events