A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of doxorubicin HCl liposome (Doxil) when
combined with carboplatin in patients with recurrent ovarian, fallopian tube, or primary
peritoneal cancer. II. Determine the toxicity of this regimen in these patients. III.
Determine the rate of response in patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study of doxorubicin HCl liposome (Doxil).
Patients receive Doxil IV over 1 hour and carboplatin IV on day 1. Treatment continues every
4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease
progression. Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 0 or 1
of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 2
years, then every 6 months for 3 years, and then annually thereafter until recurrence or
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.
Primary Purpose: Treatment
Michael Rodriguez, MD
University Hospitals Seidman Cancer Center
United States: Federal Government