NCT00314353

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

Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Bevacizumab	7.5 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.
DRUG	Oxaliplatin	130 mg/m2 IV Day 1 every 21 days for eight cycles
DRUG	Capecitabine	850 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
DRUG	Irinotecan	200 mg/m2 IV Day 1 every 21 days for eight cycles

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-05-01
• Completion: 2010-06-01
• First posted: 2006-04-13
• Last updated: 2021-10-06
• Results posted: 2008-12-02

Locations

1 site across 1 country: United States