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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097578
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : March 28, 2013
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease
Colorectal Cancer

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Study Type : Observational
Actual Enrollment : 1953 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097578

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United States, California
Genentech Central Contact
South San Francisco, California, United States, 94080
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Eric Hedrick, M.D. Genentech, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT00097578    
Other Study ID Numbers: AVF2941n
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type