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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00097578
First received: November 24, 2004
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Phase
Colorectal Cancer
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Adenocarcinoma

Further study details as provided by Genentech, Inc.:
Enrollment: 1953
Study Start Date: March 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sites were selected primarily from community-based oncology practices geographically distributed across the United States.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097578

Locations
United States, California
Genentech Central Contact
South San Francisco, California, United States, 94080
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Eric Hedrick, M.D. Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097578     History of Changes
Other Study ID Numbers: AVF2941n
Study First Received: November 24, 2004
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015