Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

NCT00159445 | Completed Phase 2

• 1 other identifier: 3C-03-12
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Interventions

gemcitabine, capecitabine DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

U.S.C./Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Syma Iqbal, M.D.

  U.S.C./Norris Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)