Loading clinical trials...

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

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

NCT00159445•University of Southern California

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (1)

U.S.C./Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

March 1, 2004

Primary Completion Date

March 1, 2007

Completion Date

November 1, 2007

Last Updated

May 22, 2014

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerColon Cancer

Interventions

gemcitabine, capecitabine

DRUG

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)