Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Genetic: DNA methylation analysis Genetic: loss of heterozygosity analysis Genetic: microsatellite instability analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | 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 |
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Microsatellite instability [ Designated as safety issue: No ]
- Loss of heterozygosity [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00897819 History of Changes |
| Other Study ID Numbers: | CDR0000534281, ECOG-E3200T1 |
| Study First Received: | May 9, 2009 |
| Last Updated: | May 9, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent colon cancer recurrent rectal cancer stage III colon cancer stage III rectal cancer |
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
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 Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013