Clinical Trials Directory

Trials / Completed

CompletedNCT00826540

Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
83 (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: I. Evaluate proportion of patients who are progression-free at 3 months (in historic comparison with results for single-agent bevacizumab in ECOG 3200). SECONDARY OBJECTIVES: I. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility OUTLINE: This is a multicenter study. Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies. After completion of study treatment, patients are followed periodically for up to 2 years.

Conditions

Interventions

TypeNameDescription
DRUGsorafenib tosylateGiven orally
BIOLOGICALbevacizumabGiven IV

Timeline

Start date
2009-09-01
Primary completion
2010-01-01
Completion
2014-02-01
First posted
2009-01-22
Last updated
2026-01-20
Results posted
2014-03-03

Locations

211 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00826540. Inclusion in this directory is not an endorsement.