Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00159445
First received: September 7, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Colon Cancer
Drug: gemcitabine, capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 53
Study Start Date: March 2004
Study Completion Date: November 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159445

Locations
United States, California
U.S.C./Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Eli Lilly and Company
Investigators
Principal Investigator: Syma Iqbal, M.D. U.S.C./Norris Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159445     History of Changes
Other Study ID Numbers: 3C-03-12
Study First Received: September 7, 2005
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014