Ovarian Cancer Clinical Trial
Official title:
A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy
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. It is
not yet known if carboplatin is more effective with or without liposomal doxorubicin in
treating recurrent ovarian epithelial or primary peritoneal cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or
without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or
primary peritoneal cancer.
OBJECTIVES:
- Compare overall survival of patients with platinum-sensitive recurrent ovarian
epithelial or primary peritoneal cancer treated with carboplatin with or without
pegylated doxorubicin HCl liposome.
- Compare progression-free survival, confirmed complete response rates, and time to
treatment failure in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease measurability (elevated CA 125 only vs nonmeasurable disease only with or without
elevated CA 125 vs measurable disease), number of disease sites (2 or fewer vs 3 or more),
and serous tumor histology (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl
liposome IV over 1 hour on day 1.
- Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats
every 4 weeks for a total of 15 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 4 weeks, every 6 months for 3 years, and then annually for 7 years.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 4 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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