Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003896

Purpose

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.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: cisplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Procedure: adjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	September 1999
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
- Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
- No tumors of borderline or low malignant potential only
- Mixed Mullerian tumors allowed
Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter
Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

SWOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic:

Bilirubin ≤ 2 times upper limit of normal (ULN)
SGOT or SGPT ≤ 2 times ULN

Renal:

Creatinine clearance ≥ 50 mL/min

Cardiovascular:

No congestive heart failure
No cardiac arrhythmia
No myocardial infarction or unstable angina within the past 6 months
Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No active or uncontrolled infection
No concurrent fever
No grade 2 or greater sensory neuropathy
No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection
No erythema or tenderness of abdominal incision or port site suggestive of underlying infection
No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy for ovarian cancer

Chemotherapy:

No prior chemotherapy for ovarian cancer

Endocrine therapy:

Not specified

Radiotherapy:

No prior pelvic radiotherapy for ovarian cancer

Surgery:

See Disease Characteristics
Recovered from all reversible surgery-related toxic effects

Other:

No other concurrent antitumor treatment
No concurrent antibiotics for infection of undetermined etiology

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003896

Hide Study Locations

Locations

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

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Harriet O. Smith, MD

University of New Mexico

Study ID Numbers:	CDR0000067066, SWOG-S9912
Study First Received:	November 1, 1999
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00003896 History of Changes
Health Authority:	United States: Federal Government