Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
No
Harriet O. Smith, MD
Study Chair
University of New Mexico Cancer Center
United States: Federal Government
CDR0000067066
NCT00003896
September 1999
February 2008
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Harrington Cancer Center | Amarillo, Texas 79106 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Wesley Medical Center | Wichita, Kansas 67214 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Great Falls Clinic | Great Falls, Montana 59405 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, P.A. | Wichita, Kansas 67208 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Mecosta County General Hospital | Big Rapids, Michigan 49307 |
Metropolitan Hospital | Grand Rapids, Michigan 49506 |
Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids, Michigan 49503 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Northern Michigan Hospital | Petoskey, Michigan 49770 |
Munson Medical Center | Traverse City, Michigan 49684 |
St. Francis Medical Center | Cape Girardeau, Missouri 63701 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
Internal Medicine Associates of Bozeman | Bozeman, Montana 59715 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
Big Sky Oncology | Great Falls, Montana 59405 |
Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Eastern Montana Cancer Center | Miles City, Montana 59301 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Central Washington Hospital | Wenatchee, Washington 98801 |
Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Summit Medical Center | Oakland, California 94609 |
Saint Rose Hospital | Hayward, California 94545 |
J.C. Robinson, M.D. Regional Cancer Center | San Pablo, California 94806 |
Salina Regional Health Center | Salina, Kansas 67401 |
Bay Regional Medical Center | Bay City, Michigan 48708 |
Doctor's Hospital of Laredo | Laredo, Texas 78041 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Valley Memorial Hospital | Livermore, California 94550 |
Highland General Hospital | Oakland, California 94602 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Spectrum Health Hospital - Blodgett Campus | Grand Rapids, Michigan 49506 |
Mercy Hospital | Port Huron, Michigan 48060 |
Salem Hospital Regional Cancer Center | Salem, Oregon 97309 |
Cancer Care Center at Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Care Center at Battle Creek Health System | Battle Creek, Michigan 49017 |
Judy L. Schmidt, MD, FACP, P. C. | Missoula, Montana 59804 |
Good Samaritan Health Systems | Kearney, Nebraska 68847 |
MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
Providence Hospital | Centralia, Washington 98531 |