Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- NSABP Foundation Inc
- Study ID
- NCT00314353
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUG7.5 mg/kg IV Day 1 every 21 days for eight cycles\* \*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
- Oxaliplatin — DRUG130 mg/m2 IV Day 1 every 21 days for eight cycles
- Capecitabine — DRUG850 mg/m2 po BID Days 1-14 every 21 days for eight cycles\*# \*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
- Irinotecan — DRUG200 mg/m2 IV Day 1 every 21 days for eight cycles
Study Details
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
Key Dates
- Start date
- Mar 31, 2006
- Status verified
- Oct 2021
- Primary completion
- May 31, 2008
- Completion
- Jun 30, 2010
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
- Experimental: 2
Primary Outcome Measure
One-year Progression-free Survival (PFS) [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NSABP Operations Center | Pittsburgh | Pennsylvania | 15212 | - |
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