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Trial record 65 of 160 for:    colon cancer AND Capecitabine AND Fluorouracil

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00159445
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
University of Southern California

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE March 2004
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
To assess time to progression in patients with metastatic colorectal cancer treated with a combination of gemcitabine and capecitabine after progressing on two or more therapies for advanced disease, and having failed both CPT-11 and Oxaliplatin bas
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00159445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • To assess the response rate and survival in patients with metastatic colorectal cancer treated with a combination of gemcitabine and capecitabine after progressing on two or more therapies for advanced disease. To assess the toxicity of this regimen.
  • To assess whether polymorphisms of thegenes involved in the 5-FU metabolic pathway are associated with efficacy of chemotherapy and toxicity.
  • To test the hypothesis that increased gene expression levels predict chemoresistance to capecitabine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer
Brief Summary This study is for patients with colorectal cancer that has spread and has increased in size after standard treatments. This study is being done to find out how long it takes their tumors to grow after treatment with the chemotherapy drugs capecitabine and gemcitabine. Capecitabine is a chemotherapy drug that has been approved by the FDA for the treatment of colorectal cancer. We are adding another drug (called gemcitabine), which is approved by the FDA for the treatment of cancer of the pancreas to see if the ability of capecitabine to shrink tumors can be improved by adding gemcitabine. The side effects of the combination will also be evaluated. Another purpose of this study is to measure the levels of certain substances that affect how the body reacts to the chemotherapy agents in cancer cells (in the tumor). In addition, the genes (which are the cell's blueprint for these substances) will also be evaluated in the blood.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Colon Cancer
Intervention  ICMJE Drug: gemcitabine, capecitabine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 7, 2005)
53
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum, with measurable disease. The primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
  • Patients must have failed CPT-11 and oxaliplatin based therapies.
  • Patients must have received at least two prior chemotherapy regimens for advanced disease (completed > 4 weeks prior to enrollment).
  • Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
  • SWOG performance status 0-2.
  • AGC >1000, platelets >100,000.
  • Total bilirubin < 3 x upper limit of normal. Transaminase (AST and/or ALT) < 2 x upper limit of normal or < 5 x upper limit of normal in patients with liver metastasis.
  • Patients must have a measured or calculated creatinine clearance greater than 35 mL/min obtained within 28 days prior to registration.
  • Age greater than or equal to 18 years
  • Patients should have hemoglobin > 9 g/dL; patients may be transfused to achieve this level of hemoglobin.
  • Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.

Exclusion Criteria:

  • History of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
  • Patients with brain metastasis.
  • History of recent (within one year) myocardial infarction or evidence of congestive heart failure.
  • Patients that have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
  • Patients should not have any immediate life-threatening complications of their malignancies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159445
Other Study ID Numbers  ICMJE 3C-03-12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Syma Iqbal, M.D. U.S.C./Norris Comprehensive Cancer Center
PRS Account University of Southern California
Verification Date May 2014

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