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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00250029
First received: November 3, 2005
Last updated: September 23, 2011
Last verified: April 2010

November 3, 2005
September 23, 2011
April 2004
September 2005   (final data collection date for primary outcome measure)
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 [ Time Frame: The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment. ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00250029 on ClinicalTrials.gov Archive Site
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Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy

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.

This is a single-arm, non-randomized trial of oxaliplatin and capecitabine. Patients that are placed on other studies that utilize the same chemotherapy regimen can enter this study. Those patients will be treated according to the clinical study on which they have been entered. For patients not on another clinical trial, the treatment outlined below should be followed.

Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colonic Diseases
  • Cancer
Drug: Oxaliplatin

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.

Other Name: XELOX (oxaplatin+capecitabine)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2006
September 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00250029
0104C
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Ian Rabinowitz, MD University of New Mexico
New Mexico Cancer Care Alliance
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP