Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Dartmouth-Hitchcock Medical Center
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted