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

NCT ID: NCT00097578

Last Updated: 2013-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1953 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Hedrick, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Genentech Central Contact

South San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22424880 (View on PubMed)

Other Identifiers

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AVF2941n

Identifier Type: -

Identifier Source: org_study_id

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