S9912 Combination Chemo in Stage III Ovarian Cancer,
- Conditions
- Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer
- Interventions
- Registration Number
- NCT00003896
- Lead Sponsor
- SWOG Cancer Research Network
- 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
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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.
Trial Locations
- Locations (104)
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸St. Louis, Missouri, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, United States
Central Washington Hospital
🇺🇸Wenatchee, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A.
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Judy L. Schmidt, MD, FACP, P. C.
🇺🇸Missoula, Montana, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Sletten Regional Cancer Institute
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Good Samaritan Health Systems
🇺🇸Kearney, Nebraska, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Eastern Montana Cancer Center
🇺🇸Miles City, Montana, United States
MedCentral - Mansfield Hospital
🇺🇸Mansfield, Ohio, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Saint Rose Hospital
🇺🇸Hayward, California, United States
University of California Davis Cancer Center
🇺🇸Davis, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Valley Memorial Hospital
🇺🇸Livermore, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Summit Medical Center
🇺🇸Oakland, California, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
J.C. Robinson, M.D. Regional Cancer Center
🇺🇸San Pablo, California, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Care Center at Battle Creek Health System
🇺🇸Battle Creek, Michigan, United States
Mecosta County General Hospital
🇺🇸Big Rapids, Michigan, United States
Bay Regional Medical Center
🇺🇸Bay City, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
🇺🇸Grand Rapids, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸East Lansing, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Hospital - Blodgett Campus
🇺🇸Grand Rapids, Michigan, United States
Metropolitan Hospital
🇺🇸Grand Rapids, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
St. Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Gape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸St. Louis, Missouri, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Deaconess Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Internal Medicine Associates of Bozeman
🇺🇸Bozeman, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
Salem Hospital Regional Cancer Center
🇺🇸Salem, Oregon, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
St. Joseph Hospital Community Cancer Center
🇺🇸Bellingham, Washington, United States
Providence Hospital
🇺🇸Centralia, Washington, United States
Auburn Regional Center for Cancer Care
🇺🇸Auburn, Washington, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Cancer Care Center at Skagit Valley Hospital
🇺🇸Mt. Vernon, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Capital Medical Center
🇺🇸Olympia, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
St. Joseph Medical Center at Franciscan Health System
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Wenatchee Valley Clinic
🇺🇸Wenatchee, Washington, United States
Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Welch Cancer Center
🇺🇸Sheridan, Wyoming, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States