Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Conditions

• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sorafenib tosylate — DRUG
  Given orally
• bevacizumab — BIOLOGICAL
  Given IV

Study Details

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

Key Dates

Start date

Sep 30, 2009

Status verified

Dec 2025

Primary completion

Jan 31, 2010

Completion

Feb 28, 2014

Study Design

Enrollment

83 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (sorafenib tosylate and bevacizumab)
  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

Primary Outcome Measure

Progression-free Survival Rate [ Time Frame: At 3 months ]

Locations (211)

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