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

This study is currently recruiting participants.

Verified by Genentech, March 2008

First Received: October 12, 2006 Last Updated: March 20, 2008 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00388206

Purpose

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.

Condition	Phase
Colorectal Cancer Non-Small Cell Lung Cancer	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Lung Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Estimated Enrollment:	4000
Study Start Date:	May 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388206

Contacts

Contact: The AIRES Call Center

866-903-4465

ariesregistry@wilm.ppd.com

Show 249 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Mary Sugrue, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc.
Study ID Numbers:	AVF3991n
Study First Received:	October 12, 2006
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00388206 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

NSCLC
Avastin
anti-VEGF
lung cancer

colorectal cancer
ARIES
Colon Cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Bevacizumab
Rectal Diseases
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Digestive System Neoplasms
Growth Substances
Intestinal Diseases
Angiogenesis Inhibitors
Pharmacologic Actions
Intestinal Neoplasms
Carcinoma
Neoplasms
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010