Breast Cancer Clinical Trial
Official title:
Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor
cells and either kill them or deliver tumor-killing substances to them without harming
normal cells.
PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in
treating patients who have refractory or metastatic breast cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of vinorelbine in combination with trastuzumab
(Herceptin) in patients with HER-2/neu overexpressing unresectable or metastatic
non-small cell lung cancer (closed to accrual as of 4/16/01) or refractory locally
advanced or metastatic breast cancer.
- Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this
patient population.
- Determine the objective response rate of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of vinorelbine.
Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8, and trastuzumab
(Herceptin) IV over 30-90 minutes on days 8 and 15 of course 1 and days 1, 8, and 15 of all
subsequent courses. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of vinorelbine until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients
experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 30-35 patients will be accrued for this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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