First-line Therapy of Stage IV Colorectal Cancer
- Sponsor
- University of Cologne
- Study ID
- NCT00784446
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Stage IV Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Oxaliplatin, Capecitabine, Bevacizumab, Imatinib — DRUGDose level I: Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 100 mg/m2 Capecitabine days 1-14 bid: 800 mg/m2 Imatinib days 1-21: 300 mg Repeat on day 22. Dose level II: Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 130 mg/m2 Capecitabine days 1-14 bid: 1000 mg/m2 Imatinib days 1-21: 300 mg Repeat on day 22.
Study Details
Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.
Key Dates
- First listed
- Nov 4, 2008
- Start date
- Apr 30, 2008
- Status verified
- Jan 2013
- Primary completion
- Aug 31, 2010
- Completion
- Dec 31, 2012
Study Design
- Enrollment
- 51 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- No Intervention: XELOX, Bevacizumab, Imatinib
Primary Outcome Measure
Dose limiting toxicity. [ Time Frame: 6 weeks ]