S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian 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. 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.
Peritoneal Cavity Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- overall survival [ Time Frame: ten years ] [ Designated as safety issue: No ]From date of registration to date of death
- progression free survival and response [ Time Frame: 10 years ] [ Designated as safety issue: No ]response by RECIST criteria
- side effects [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]side effects described per NCI CTC version 2.0
|Study Start Date:||August 2002|
|Study Completion Date:||July 2011|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: carboplatin and doxorubicin
carboplatin and liposomal doxorubicin given q 4 weeks
intravenous q 4 weeksDrug: pegylated liposomal doxorubicin hydrochloride
intravenous q 4 weeks
Active Comparator: carboplatin
intravenous q 4 weeks
- 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.