NCT00116506

Study of Bevacizumab, Erlotinib, FOLFOX for Patients With Untreated Metastatic Colorectal Cancer

A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (planned)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite recent advances, most patients with advanced colorectal cancer continue to have a poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin are considered traditional chemotherapies that try to stop tumor growth by affecting how they divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow. It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown to be effective in treating lung and other cancers. This trial is assessing the potential benefit of adding these second targeted agents to standard treatment.

Detailed description

* Patients receive bevacizumab, oxaliplatin, leucovorin, and 5-FU intravenously. The erlotinib is taken orally each day. One cycle of study therapy is 14 days. Cycles may be repeated unless there are intolerable side effects or the cancer worsens. * Patients will undergo a tumor measurement evaluation following 3 cycles of study therapy, and then every 4 cycles thereafter.

Conditions

• Colorectal Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	erlotinib
DRUG	FOLFOX
DRUG	bevacizumab

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-06-30
• Last updated: 2007-12-21

Locations

3 sites across 1 country: United States