NCT00022152

Vinorelbine in Treating Older Women With Stage IV Breast Cancer

Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	vinorelbine tartrate

Timeline

• Start date: 2001-11-01
• Primary completion: 2006-03-01
• Completion: 2007-08-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

18 sites across 1 country: United States