Phase I - II Study of Doxil® In Combination With Daily Oral Cyclophosphamide and Herceptin for Patients With HER-2/Neu Positive Disease In Patients With Metastatic Breast Cancer
PRIMARY OBJECTIVES: I. To determine the optimal tolerated dose of Doxil when given in
combination with daily oral cyclophosphamide in patients with stage IV breast cancer. (Phase
I) II. To determine the efficacy (overall clinical response rate) of the optimal tolerated
dose of Doxil when given in combination with daily oral cyclophosphamide and herceptin (for
HER2 neu positive patients) in patients with stage IV breast cancer. (Phase II) SECONDARY
OBJECTIVES: I. To assess the treatment related toxicity associated with each dose level of
this regimen and assess efficacy (overall clinical response rate). (Phase I) II. To assess
the safety (treatment related toxicity) of the optimal tolerated dose of Doxil when given in
combination with daily oral cyclophosphamide and herceptin (for HER2 neu positive patients)
in patients with stage IV breast cancer. (Phase II) III. To assess time to progression and
overall survival following treatment with Doxil and daily oral cyclophosphamide and
herceptin (for HER2 neu positive patients). (Phase II) IV. To compare the response rate in
patients who are heavily pretreated to the response rate in patients who are less heavily
pretreated. OUTLINE: This is a phase I, dose-escalation study of pegylated doxorubicin HCl
liposome followed by a phase II feasibility study. Patients receive oral cyclophosphamide
once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1.
Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable
toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90
minutes weekly or every 3 weeks at the discretion of the treating physician. After
completion of study treatment, patients are followed up every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and optimal tolerated dose of pegylated liposomal doxorubicin hydrochloride (Doxil) when given in combination with cyclophosphamide (Phase I)
At the dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment
Yes
Hannah Linden
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
6139
NCT00331552
February 2006
Name | Location |
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |