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Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer (NCT00003896)

National Cancer Institute (NCI)
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.
  • Drug: cisplatin
    • platinol
  • Drug: liposomal doxorubicin
    • pegylated liposomal doxorubicin hydrochloride
    • doxil
  • Drug: paclitaxel
    • taxol
Ages eligible for Study
all
Genders eligible for Study
Female
Accepts Healthy Volunteers
No
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.

104 locations

United States (104)
  • Arizona Cancer Center at University of Arizona Health Sciences Center
    Tucson, Arizona, United States, 85724
  • University of California Davis Cancer Center
    Davis, California, United States, 95616
  • City of Hope Comprehensive Cancer Center
    Duarte, California, United States, 91010
  • Saint Rose Hospital
    Hayward, California, United States, 94545
  • Valley Memorial Hospital
    Livermore, California, United States, 94550
  • Highland General Hospital
    Oakland, California, United States, 94602
  • CCOP - Bay Area Tumor Institute
    Oakland, California, United States, 94609
  • Summit Medical Center
    Oakland, California, United States, 94609
  • J.C. Robinson, M.D. Regional Cancer Center
    San Pablo, California, United States, 94806
  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
    Valdosta, Georgia, United States, 31603
  • St. Luke's Mountain States Tumor Institute - Boise
    Boise, Idaho, United States, 83712
  • Saint Anthony's Hospital at Saint Anthony's Health Center
    Alton, Illinois, United States, 62002
  • Good Samaritan Regional Health Center
    Mt. Vernon, Illinois, United States, 62864
  • Cancer Center of Kansas - Chanute
    Chanute, Kansas, United States, 66720
  • Cancer Center of Kansas - Dodge City
    Dodge City, Kansas, United States, 67801
  • Cancer Center of Kansas, P.A. - El Dorado
    El Dorado, Kansas, United States, 67042
  • Cancer Center of Kansas - Kingman
    Kingman, Kansas, United States, 67068
  • Southwest Medical Center
    Liberal, Kansas, United States, 67901
  • Cancer Center of Kansas - Newton
    Newton, Kansas, United States, 67114
  • Cancer Center of Kansas, P.A. - Parsons
    Parsons, Kansas, United States, 67357
  • Pratt Cancer Center of Kansas
    Pratt, Kansas, United States, 67124
  • Cancer Center of Kansas - Salina
    Salina, Kansas, United States, 67042
  • Salina Regional Health Center
    Salina, Kansas, United States, 67401
  • Cancer Center of Kansas - Wellington
    Wellington, Kansas, United States, 67152
  • Associates in Womens Health
    Wichita, Kansas, United States, 67203
  • Cancer Center of Kansas, P.A.
    Wichita, Kansas, United States, 67208
  • Cancer Center of Kansas, P.A. - Wichita
    Wichita, Kansas, United States, 67214
  • CCOP - Wichita
    Wichita, Kansas, United States, 67214
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas, United States, 67214
  • Wesley Medical Center
    Wichita, Kansas, United States, 67214
  • Cancer Center of Kansas - Winfield
    Winfield, Kansas, United States, 67156
  • Cancer Care Center at Battle Creek Health System
    Battle Creek, Michigan, United States, 49017
  • Bay Regional Medical Center
    Bay City, Michigan, United States, 48708
  • Mecosta County General Hospital
    Big Rapids, Michigan, United States, 49307
  • Breslin Cancer Center at Ingham Regional Medical Center
    East Lansing, Michigan, United States, 48824-1313
  • CCOP - Grand Rapids
    Grand Rapids, Michigan, United States, 49503
  • Lacks Cancer Center at Saint Mary's Mercy Medical Center
    Grand Rapids, Michigan, United States, 49503
  • Spectrum Health Cancer Care - Butterworth Campus
    Grand Rapids, Michigan, United States, 49503
  • Metropolitan Hospital
    Grand Rapids, Michigan, United States, 49506
  • Spectrum Health Hospital - Blodgett Campus
    Grand Rapids, Michigan, United States, 49506
  • Holland Community Hospital
    Holland, Michigan, United States, 49423
  • Hackley Hospital
    Muskegon, Michigan, United States, 49443
  • Northern Michigan Hospital
    Petoskey, Michigan, United States, 49770
  • Mercy Hospital
    Port Huron, Michigan, United States, 48060
  • Munson Medical Center
    Traverse City, Michigan, United States, 49684
  • St. Francis Medical Center
    Cape Girardeau, Missouri, United States, 63701
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
    Gape Girardeau, Missouri, United States, 63701
  • CCOP - St. Louis-Cape Girardeau
    St. Louis, Missouri, United States, 63141
  • David C. Pratt Cancer Center at St. John's Mercy
    St. Louis, Missouri, United States, 63141
  • CCOP - Montana Cancer Consortium
    Billings, Montana, United States, 59101
  • Deaconess Billings Clinic - Downtown
    Billings, Montana, United States, 59101
  • Hematology-Oncology Centers of the Northern Rockies - Billings
    Billings, Montana, United States, 59101
  • Northern Rockies Radiation Oncology Center
    Billings, Montana, United States, 59101
  • St. Vincent Healthcare
    Billings, Montana, United States, 59101
  • Deaconess Billings Clinic Cancer Center
    Billings, Montana, United States, 59107
  • Bozeman Deaconess Hospital
    Bozeman, Montana, United States, 59715
  • Internal Medicine Associates of Bozeman
    Bozeman, Montana, United States, 59715
  • St. James Community Hospital
    Butte, Montana, United States, 59701
  • Big Sky Oncology
    Great Falls, Montana, United States, 59405
  • Great Falls Clinic
    Great Falls, Montana, United States, 59405
  • Sletten Regional Cancer Institute
    Great Falls, Montana, United States, 59405
  • St. Peter's Hospital
    Helena, Montana, United States, 59601
  • Glacier Oncology, PLLC
    Kalispell, Montana, United States, 59901
  • Kalispell Medical Oncology
    Kalispell, Montana, United States, 59901
  • Kalispell Regional Medical Center
    Kalispell, Montana, United States, 59901
  • Eastern Montana Cancer Center
    Miles City, Montana, United States, 59301
  • Community Medical Center
    Missoula, Montana, United States, 59801
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    Missoula, Montana, United States, 59802
  • Montana Cancer Specialists at Montana Cancer Center
    Missoula, Montana, United States, 59802
  • Judy L. Schmidt, MD, FACP, P. C.
    Missoula, Montana, United States, 59804
  • Good Samaritan Health Systems
    Kearney, Nebraska, United States, 68847
  • Wayne Memorial Hospital, Incorporated
    Goldsboro, North Carolina, United States, 27534
  • Rutherford Hospital
    Rutherfordton, North Carolina, United States, 28139
  • MedCentral - Mansfield Hospital
    Mansfield, Ohio, United States, 44903
  • Salem Hospital Regional Cancer Center
    Salem, Oregon, United States, 97309
  • Rose Ramer Cancer Clinic at Anderson Area Medical Center
    Anderson, South Carolina, United States, 29621
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    Spartanburg, South Carolina, United States, 29303
  • Harrington Cancer Center
    Amarillo, Texas, United States, 79106
  • Doctor's Hospital of Laredo
    Laredo, Texas, United States, 78041
  • Huntsman Cancer Institute at University of Utah
    Salt Lake City, Utah, United States, 84112
  • Danville Regional Medical Center
    Danville, Virginia, United States, 24541
  • Auburn Regional Center for Cancer Care
    Auburn, Washington, United States, 98002
  • St. Joseph Hospital Community Cancer Center
    Bellingham, Washington, United States, 98225
  • Olympic Hematology and Oncology
    Bremerton, Washington, United States, 98310
  • Providence Hospital
    Centralia, Washington, United States, 98531
  • St. Francis Hospital
    Federal Way, Washington, United States, 98003
  • Cancer Care Center at Skagit Valley Hospital
    Mt. Vernon, Washington, United States, 98273
  • Providence St. Peter Hospital Regional Cancer Center
    Olympia, Washington, United States, 95806
  • Capital Medical Center
    Olympia, Washington, United States, 98507
  • Good Samaritan Cancer Center
    Puyallup, Washington, United States, 98372
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington, United States, 98104
  • Group Health Central Hospital
    Seattle, Washington, United States, 98104
  • Harborview Medical Center
    Seattle, Washington, United States, 98104
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    Seattle, Washington, United States, 98114
  • University Cancer Center at University of Washington Medical Center
    Seattle, Washington, United States, 98195
  • Cancer Care Northwest - Spokane South
    Spokane, Washington, United States, 99202
  • Allenmore Hospital
    Tacoma, Washington, United States, 98405
  • CCOP - Northwest
    Tacoma, Washington, United States, 98405
  • St. Joseph Medical Center at Franciscan Health System
    Tacoma, Washington, United States, 98405
  • St. Clare Hospital
    Tacoma, Washington, United States, 98499
  • Central Washington Hospital
    Wenatchee, Washington, United States, 98801
  • Wenatchee Valley Clinic
    Wenatchee, Washington, United States, 98801
  • Camden-Clark Memorial Hospital
    Parkersburg, West Virginia, United States, 26101
  • Welch Cancer Center
    Sheridan, Wyoming, United States, 82801
Participant Flow: Overall Study
Paclitaxel/CDDP/Lipo Doxorubicin
Serious Adverse Events
Paclitaxel/CDDP/Liposomal Doxorubicin
Other Adverse Events
Paclitaxel/CDDP/Liposomal Doxorubicin
Status:
completed
Type:
Interventional
Phase:
Start:
31 August, 1999
Updated:
01 January, 2013
Participants:
68
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