Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen

NCT00250029 | Completed DMC

• 1 other identifier: 0104C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen. 1.2 To determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients.

Conditions

Colonic Diseases; Cancer

Keywords

Colorectal Cancer; Pilot Study; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen

  The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment.

Interventions

Oxaliplatin DRUG

Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2 hour intravenous infusion on day 1 of a three week cycle, prior to the 1st dose of capecitabine. 5-HT3 antagonists with or without dexamethasone premedication are strongly recommended. Oxaliplatin may be infused either through a peripheral vein or a central venous line. The infusion lines must be adequately flushed with 5% dextrose solution (D5W) between oxaliplatin infusion \& the administration of any other drug. Capecitabine is to be administered orally within 30 mins. after the end of a meal. Tablets should be swallowed with approximately 200 mL water (not fruit juices). The first dose of each cycle will be administered as the evening dose on day 1 \& the last dose of each cycle is scheduled the morning of day 15, followed by a 7 day rest period. This provides for a total of 28 single doses per cycle over 15 calendar days.

Also known as: XELOX (oxaplatin+capecitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients, \>18 years of age, with metastatic/recurrent colorectal cancer are eligible.
• Patients must have a life expectancy of at least 12 weeks.
• Patients must have a Zubrod performance status of 0-2.
• Patients must sign an informed consent.
• Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \> 100,000/mm3 and absence of a regular red blood cell transfusion requirement.
• Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
• The patient must agree to a biopsy of a sample of tumor for correlative studies.
• The patient is an appropriate candidate for oxaliplatin/capecitabine based chemotherapy.
• The patient must have measurable disease.

You may not qualify if:

• Patients with symptomatic brain metastases are excluded from this study.
• Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
• Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
• Patients may not have received oxaliplatin previously.
• Patients with a prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency, or known hypersensitivity to platinum compounds or any of the components of the study medications.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (4)

Hematology Oncology Associates

Albuquerque, New Mexico, 87102-3661, United States

Location

Lovelace Sandia Health Systems Dept of Hematology

Albuquerque, New Mexico, 87108, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

New Mexico Veterans Administration Health Care System

Albuquerque, New Mexico, United States

Location

MeSH Terms

Conditions

Colonic Diseases; Neoplasms; Colorectal Neoplasms

Interventions

Oxaliplatin; XELOX

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Ian Rabinowitz, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: April 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: March 1, 2006
• Last Updated: September 27, 2011

Record last verified: 2010-04

Locations

US (4)