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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
intravenous q 4 weeks
intravenous q 4 weeks
MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
overall survival
From date of registration to date of death
Time frame: ten years
progression free survival and response
response by RECIST criteria
Time frame: 10 years
side effects
side effects described per NCI CTC version 2.0
Time frame: 15 months
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
California Cancer Center at Woodward Park Office
Fresno, California, United States
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States
...and 81 more locations