Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer - Full Text View

Sponsors and Collaborators:	Norris Comprehensive Cancer Center Eli Lilly and Company
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00159445

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

Further study details as provided by Norris Comprehensive Cancer Center:

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

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

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

Norris Comprehensive Cancer Center

Eli Lilly and Company

Investigators

Principal Investigator:

Syma Iqbal, M.D.

U.S.C./Norris Comprehensive Cancer Center

More Information

Study ID Numbers:	3C-03-12
Study First Received:	September 7, 2005
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00159445
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Gemcitabine
Intestinal Diseases
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009