S9912 Combination Chemo in Stage III 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.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Drug: liposomal doxorubicin
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free Survival [ Time Frame: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter. ] [ Designated as safety issue: No ]From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
- Overall Survival [ Time Frame: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter. ] [ Designated as safety issue: No ]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
- Adverse Events [ Time Frame: Weekly during 6 weeks of protocol treatment ] [ Designated as safety issue: Yes ]Only adverse events that are possibly, probably or definitely related to study drug are reported.
|Study Start Date:||September 1999|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Experimental: Paclitaxel/cisplatin/Liposomal Doxorubicin
paclitaxel, cisplatin and liposomal doxorubicin
Other Name: platinolDrug: liposomal doxorubicin
Other Names:Drug: paclitaxel
Other Name: taxol
- 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.