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

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ClinicalTrials.gov Identifier: NCT00097578
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
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.
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents