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