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

This study is ongoing, but not recruiting participants.

First Received on October 12, 2006. Last Updated on November 17, 2011 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:	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 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:

Enrollment:	3998
Study Start Date:	May 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

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

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Mary Sugrue, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00388206 History of Changes
Other Study ID Numbers:	AVF3991n
Study First Received:	October 12, 2006
Last Updated:	November 17, 2011
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:

Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012