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Vinorelbine in Treating Older Women With Stage IV Breast Cancer

2014-08-27 03:56:41 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.

Description

OBJECTIVES:

- Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.

- Determine the toxicity profile of this drug in these patients.

- Determine the time to progression in patients treated with this drug.

- Determine the quality of life of patients treated with this drug.

- Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7-18 months.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

vinorelbine ditartrate

Location

CCOP - Scottsdale Oncology Program
Scottsdale
Arizona
United States
85259-5404

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:41-0400

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