Breast Cancer Clinical Trial
Official title:
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]
RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for
their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either
kill them or deliver tumor-killing substances to them without harming normal cells. Giving
GW572016 with trastuzumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given
together with trastuzumab in treating patients with metastatic breast cancer that
overexpresses HER2/neu.
OBJECTIVES:
Primary
- Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab
(Herceptin^®) in patients with metastatic breast cancer that overexpresses HER2/neu.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the clinical response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter, dose-escalation study of GW572016.
Patients receive oral GW572016 once daily on days 1-28 and trastuzumab (Herceptin^®) IV over
90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GW572016 until the optimally tolerated
regimen (OTR) is determined. The OTR is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the OTR is determined, 10-18 additional
patients are entered and treated at the OTR.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
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