A Study of Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 12, 2006

Last Updated Date

March 20, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00388206 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES)

Official Title ^ICMJE

An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy for Treatment of Metastatic or Locally Advanced and Unresectable Colorectal Cancer and Locally Advanced or Metastatic Non-Small Cell Lung (Excluding Predominant Squamous Cell Histology)

Brief Summary

This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC, locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible. Patients who started their Avastin containing therapy <3 months prior to enrollment are eligible.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Colorectal Cancer
Non-Small Cell Lung Cancer

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

4000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed Informed Consent Form
Metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology)
Eligible for Avastin as a component of intended therapy
First-line chemotherapy (or second-line chemotherapy for CRC) plus Avastin initiated ≤ 3 months prior to study enrollment

Exclusion Criteria:

Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment and follow-up, as specified by the investigator
Enrollment in a blinded, placebo-controlled bevacizumab trial

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: The AIRES Call Center

866-903-4465

ariesregistry@wilm.ppd.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00388206

Responsible Party

Genentech, Inc.

Study ID Numbers ^ICMJE

AVF3991n

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mary Sugrue, M.D.

Genentech

Information Provided By

Genentech

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP