S9912 Combination Chemo in Stage III Ovarian Cancer,

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Paclitaxel/cisplatin/Liposomal Doxorubicin	liposomal doxorubicin	paclitaxel, cisplatin and liposomal doxorubicin
Paclitaxel/cisplatin/Liposomal Doxorubicin	paclitaxel	paclitaxel, cisplatin and liposomal doxorubicin
Paclitaxel/cisplatin/Liposomal Doxorubicin	cisplatin	paclitaxel, cisplatin and liposomal doxorubicin

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.	From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Overall Survival	Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.	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

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Weekly during 6 weeks of protocol treatment	Only adverse events that are possibly, probably or definitely related to study drug are reported.

Locations (104): Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸
Tucson, Arizona, United States
University of California Davis Cancer Center
🇺🇸
Davis, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸
Duarte, California, United States
Saint Rose Hospital
🇺🇸
Hayward, California, United States
Valley Memorial Hospital
🇺🇸
Livermore, California, United States
Highland General Hospital
🇺🇸
Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸
Oakland, California, United States
Summit Medical Center
🇺🇸
Oakland, California, United States
J.C. Robinson, M.D. Regional Cancer Center
🇺🇸
San Pablo, California, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸
Valdosta, Georgia, United States
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Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States