RATIONALE: Drugs used in chemotherapy work in 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 II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
OBJECTIVES: * Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer. * Determine the feasibility of and toxic effects associated with this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Progression-free Survival
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Time frame: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
Overall Survival
from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact
Time frame: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.
Adverse Events
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Weekly during 6 weeks of protocol treatment
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Arizona Cancer Center at University of Arizona Health Sciences Center
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