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

May 17, 2017 updated by: ECOG-ACRIN Cancer Research Group

Evaluation of the Association Between DNA Methylation and Shortened Survival in Patients With Advanced Colorectal Cancer Treated With 5-FU/Oxaliplatin-Based Regimens in E3200

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.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples submitted for research from patients participating in E3200

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of MSI and LOH to outcome and response Time Frame: 1 month	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Stanley Hamilton, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2007

Primary Completion (Actual)

January 30, 2008

Study Completion (Actual)

January 30, 2008

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria