Ovarian Cancer Clinical Trial
Official title:
Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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