Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2007 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on May 9, 2009. Last Updated on May 16, 2009 History of Changes

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00897754

Purpose

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.

Condition	Intervention
Colorectal Cancer	Genetic: gene expression analysis Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunoenzyme technique Other: immunohistochemistry staining method Other: immunologic technique

Study Type:	Observational
Official Title:	Alternative Splice Forms of VEGF in Colorectal Cancer - Possible Value in Anti-VEGF Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Mean scores for VEGFb and pan-VEGF gene expression by IHC [ Designated as safety issue: No ]
Comparison of outcome of bevacizumab treatment for groups on either side of the median split of VEGFb:pan-VEGF expression ratios [ Designated as safety issue: No ]
Gene expression as measured by tissue microarrays [ Designated as safety issue: No ]
Splice form expression as measured by reverse transcriptase-PCR [ Designated as safety issue: No ]
VEGF165b protein expression as measured by ELISA [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2007

Detailed Description:

OBJECTIVES:

Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy.

OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum
- Receiving bevacizumab on clinical trial E-3200

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897754

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

David Bates, PhD

Bristol Heart Institute at University of Bristol

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00897754 History of Changes
Other Study ID Numbers:	CDR0000560986, ECOG-E3200T2
Study First Received:	May 9, 2009
Last Updated:	May 16, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent rectal cancer
stage III rectal cancer

stage IV rectal cancer
recurrent colon cancer
stage III colon cancer
stage IV colon cancer

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on February 09, 2012