NCT00085020

GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu

A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	trastuzumab
DRUG	lapatinib ditosylate

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-12-01
• Completion: 2005-02-01
• First posted: 2004-06-11
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States