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
- 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
- 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
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
Peter A. Kaufman, MD
Norris Cotton Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|