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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: Completed Phase 2 study, sponsored by University of Southern California.

NCT00159445 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
University of Southern California

617 total trials

What the finished NCT00159445 record still lists

NCT00159445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

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

NCT00159445 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00159445's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00159445, the US trial registry maintained by the National Library of Medicine. NCT00159445 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.