A Study of Avastin With Chemotherapy for Treatment of Metastatic or Advanced and Unresectable Colorectal Adenocarcinoma

Colorectal Cancer Clinical Trial

Official title:

An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097578
• Other study ID #: AVF2941n
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2004
• Last updated: March 26, 2013
• Start date: March 2004
• Est. completion date: July 2008

Study information

• Verified date: March 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is an observational study designed to follow patients with metastatic or locally advanced and unresectable colorectal cancer who are receiving Avastin in combination with chemotherapy and whose cancer has been either previously untreated or treated <=4 months prior to enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1953
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Signed Informed Consent and Authorization document

• Metastatic, or locally advanced and unresectable, adenocarcinoma of the colon or rectum

• Receiving Avastin as a component of first-line chemotherapy

• First-line chemotherapy plus Avastin initiated <=4 months prior to enrollment in the study

Exclusion Criteria:

• Patients who have contraindications for treatment with Avastin (see the Avastin Package Insert) or who would incur excessive risks with Avastin treatment are ineligible for this study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Cancer

Locations

Country	Name	City	State
United States	Genentech Central Contact	South San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States,