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NCT00159445 · ClinicalTrials.gov registry record · Phase 2

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer

A Phase 2 study, sponsored by University of Southern California.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT00159445 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 53 participants.

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The verdict

NCT00159445, a Phase 2 study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study 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.

Interventions

  • DRUG gemcitabine, capecitabine

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2004-03
Est. Completion 2007-11
Phase Phase 2

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT00159445

The ClinicalTrials.gov registry entry for NCT00159445 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which gemcitabine, capecitabine is the first listed.

NCT00159445 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00159445 about?

NCT00159445 is a clinical study titled "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 ...

What is the current status of trial NCT00159445?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2004-03. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00159445?

The interventions under investigation include: gemcitabine, capecitabine (DRUG).

Who is sponsoring clinical trial NCT00159445?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.