NCT00598156

Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva

Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).

Detailed description

Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	erlotinib (Tarceva)	Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)
DRUG	bevacizumab (Avastin)	Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-10-01
• Completion: 2012-08-01
• First posted: 2008-01-18
• Last updated: 2013-04-22

Locations

15 sites across 2 countries: Denmark, Sweden