Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
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 death.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006235
|Study Chair:||Michael Rodriguez, MD||University Hospitals Seidman Cancer Center|