S9804: Vinorelbine in Treating Patients With Stage IV Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy|
|Study Start Date:||May 1999|
|Study Completion Date:||March 2004|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
vinorelbine 30 mg/m2/week IV bolus over approximately 6-10 minutes
Other Name: navelbine
OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and quantitative toxic effects of vinorelbine in these patients.
OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues in the absence of disease progression, unacceptable toxicity, or complete response to therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.