A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
- Conditions
- advanced and/or recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000009280
- Lead Sponsor
- PO Japan Southwest Oncology Research Support Organization(JSWOG)
- Brief Summary
51 patients were enrolled in this study. Median PFS was 5.5 months, and median OS was 13.5 months. The RR was 14.6%, and the DCR was 66.7%. Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand-foot syndrome. In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 51
Not provided
(1) Massive pleural effusion or ascites that required drainage (2) Severe liver disease (3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment (4) Severe renal failure (5) Metastases to the CNS (6) History of active double cancer within 5 years (7) Complication of cerebrovascular disease or symptoms within 1 year (8) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week (9) Radiation therapy within 4 weeks before enrollment (10) Administering antithrombotic drug within 10 days before enrollment (11) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day) (12) A bleeding tendency, coagulation disorder or abnormal coagulation factor (13) Uncontrollable peptic ulcer (14) History of gastrointestinal perforation within 1 year. (15) Patient with untreated traumatic bone fracture (16) Uncontrollable hypertension (17) Serious heart disease (18) History of severe allergy with 5-FU (19) Uncontrollable diarrhea (20) Interstitial pneumonitis (21) Inability of oral Agent intake (22) Requiring novel immunosuppressant and steroid (23) Receiving atazanavir sulfate (24) Severe infection disease (25) Treatment history of CPT-11 (26) 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 and safety
- Secondary Outcome Measures
Name Time Method overall survival,time to progression, and safety,Response rate,Dose Intensity,and Analysis of the safety and efficacy of CPT-11-containing regimens based on genetic polymorphisms UGT1As