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NCT00194727 · ClinicalTrials.gov registry record · Phase 2

Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer

A Phase 2 study, sponsored by University of Washington.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00194727 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 40 participants.

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The verdict

NCT00194727, a Phase 2 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.

Interventions

  • DRUG Capecitabine
  • DRUG Vinorelbine

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2002-05
Est. Completion 2011-03
Phase Phase 2

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT00194727

The ClinicalTrials.gov registry entry for NCT00194727 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.

NCT00194727 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00194727 about?

NCT00194727 is a clinical study titled "Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer". The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Sa...

What is the current status of trial NCT00194727?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2002-05. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00194727?

The interventions under investigation include: Capecitabine (DRUG), Vinorelbine (DRUG).

Who is sponsoring clinical trial NCT00194727?

This trial is sponsored by University of Washington, which has 1,048 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.