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


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

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

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

Kabbinavar FF, Flynn PJ, Kozloff M, Ashby MA, Sing A, Barr CE, Grothey A. Gastrointestinal perforation associated with bevacizumab use in metastatic colorectal cancer: results from a large treatment observational cohort study. Eur J Cancer. 2012 May;48(8):1126-32. doi: 10.1016/j.ejca.2012.02.052. Epub 2012 Mar 15.


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

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

ClinicalTrials.gov processed this record on June 23, 2017

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