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NCT Number: NCT00159445

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

U.S.C./Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gemcitabine, capecitabine

Drug

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

  1. 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.

  2. To assess whether polymorphisms of thegenes involved in the 5-FU metabolic pathway are associated with efficacy of chemotherapy and toxicity.

  3. To test the hypothesis that increased gene expression levels predict chemoresistance to capecitabine.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Phase II Study of Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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