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

NCT00194727 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-09-13

No results posted yet for this 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.

Conditions

  • Breast Neoplasm

Interventions

DRUG

Vinorelbine

20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.

DRUG

Capecitabine

825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.

Sponsors & Collaborators

Principal Investigators

  • Georgiana K. Ellis, M.D. · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194727 on ClinicalTrials.gov