Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200

NCT ID: NCT00897819

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-03

Study Completion Date

2008-01-30

Brief Summary

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RATIONALE: Studying samples of blood, urine, and 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 predict how patients respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

Detailed Description

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OBJECTIVES:

* Determine the CpG island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.
* Compare the methylation results to clinicopathologic and molecular findings and survival.

OUTLINE: This is a multicenter study.

Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14, and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346, and D17S250.

PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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DNA methylation analysis

Intervention Type GENETIC

loss of heterozygosity analysis

Intervention Type GENETIC

microsatellite instability analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of the colon or rectum

* Advanced disease
* Enrolled on clinical trial E-3200 and received fluorouracil and oxaliplatin
* Tumor tissue blocks available
* Routine pathology specimens (i.e., blood, urine) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stanley Hamilton, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Other Identifiers

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ECOG-E3200T1

Identifier Type: -

Identifier Source: secondary_id

CDR0000534281

Identifier Type: -

Identifier Source: org_study_id

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