NCT01249638

Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC

Randomized, Open, Multicenter Phase III Study With Capecitabine Plus Bevacizumab Versus Capecitabine Plus Irinotecan Plus Bevacizumab as First-line Therapy in Patients With Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patient with multiple metastases, not eligible for surgery, might not profit from intensive chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease control may be a better choice for first line treatment. Therefore this study investigates the combination of capecitabine and bevacizumab versus the combination of capecitabine, bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is time-of-failure strategy (TFS) comparing both treatment arms.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21
DRUG	Bevacizumab	Bevacizumab: 7.5 mg/kg day 1 q day 21
DRUG	Capecitabine	Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21
DRUG	Irinotecan	Irinotecan: 200 mg/m2 day 1 , q day 21
DRUG	Bevacizumab	Bevacizumab: 7.5 mg/kg day 1, q day 21

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2016-12-01
• First posted: 2010-11-30
• Last updated: 2011-03-14

Locations

1 site across 1 country: Germany