Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388206
Recruitment Status : Completed
First Posted : October 16, 2006
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or 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 <4 months prior to enrollment are eligible.

Condition or disease
Colorectal Cancer Non-Small Cell Lung Cancer

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 3998 participants
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 Cancer (Excluding Predominant Squamous Cell Histology)
Study Start Date : May 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
blood and tumor

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 ≤ 4 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388206


Sponsors and Collaborators
Genentech, Inc.
Investigators
Layout table for investigator information
Study Director: Clinical Trials Genentech, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00388206    
Other Study ID Numbers: AVF3991n
First Posted: October 16, 2006    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012
Keywords provided by Genentech, Inc.:
NSCLC
Avastin
anti-VEGF
lung cancer
 colorectal cancer
ARIES
Colon Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases