Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Phase 1
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00345761
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
- Detailed Description
This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Adult patients 20-74 years of age
- Histologically confirmed colorectal cancer
- Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
- At least one measurable lesion according to RECIST
Exclusion Criteria
- Evidence of clinically detectable ascites at study treatment start
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer, or bone fracture
- Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Step 2 Oxaliplatin - Step 1 Capecitabine - Step 2 Capecitabine - Step 3 Capecitabine - Step 1 Oxaliplatin - Step 2 Bevacizumab - Step 3 Bevacizumab - Step 3 Oxaliplatin -
- Primary Outcome Measures
Name Time Method Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) event driven Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) throughout study
- Secondary Outcome Measures
Name Time Method time to progression event driven overall survival event driven time to response event driven duration of response event driven concentrations of R340 and its metabolites throughout study concentrations of platinum throughout study concentrations of bevacizumab throughout study concentrations of vascular endothelial growth factor (VEGF) throughout study concentrations of anti-bevacizumab antibody throughout study
Trial Locations
- Locations (4)
Tokai Region
🇯🇵Tokai, Japan
Hokkaido Region
🇯🇵Hokkaido, Japan
Kanto Region
🇯🇵Kanto, Japan
Kinki Region
🇯🇵Kinki, Japan