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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Colon Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C./Norris Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

3C-03-12

NCT ID:

NCT00159445

Start Date:

March 2004

Completion Date:

November 2007

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

U.S.C./Norris Comprehensive Cancer CenterLos Angeles, California  90033