S9912 Combination Chemo in Stage III Ovarian Cancer,

NCT ID: NCT00003896

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2008-02-29

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel/cisplatin/Liposomal Doxorubicin

paclitaxel, cisplatin and liposomal doxorubicin

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

liposomal doxorubicin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Interventions

cisplatin

Intervention Type: DRUG

liposomal doxorubicin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Other Intervention Names

platinol; pegylated liposomal doxorubicin hydrochloride; doxil; taxol

Eligibility Criteria

Inclusion 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harriet O. Smith, MD

Role: STUDY_CHAIR

University of New Mexico Cancer Center

Locations

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

University of California Davis Cancer Center

Davis, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Saint Rose Hospital

Hayward, California, United States

Valley Memorial Hospital

Livermore, California, United States

Highland General Hospital

Oakland, California, United States

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Summit Medical Center

Oakland, California, United States

J.C. Robinson, M.D. Regional Cancer Center

San Pablo, California, United States

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 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

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Kingman

Kingman, Kansas, United States

Southwest Medical Center

Liberal, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, United States

Pratt Cancer Center of Kansas

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates in Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas, P.A.

Wichita, Kansas, United States

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, United States

CCOP - Wichita

Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Cancer Care Center at Battle Creek Health System

Battle Creek, Michigan, United States

Bay Regional Medical Center

Bay City, Michigan, United States

Mecosta County General Hospital

Big Rapids, Michigan, United States

Breslin Cancer Center at Ingham Regional Medical Center

East Lansing, 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

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, United States

Metropolitan Hospital

Grand Rapids, Michigan, United States

Spectrum Health Hospital - Blodgett Campus

Grand Rapids, Michigan, United States

Holland Community Hospital

Holland, Michigan, United States

Hackley Hospital

Muskegon, Michigan, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

Mercy Hospital

Port Huron, Michigan, United States

Munson Medical Center

Traverse City, 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

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Deaconess Billings Clinic - Downtown

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

St. Vincent Healthcare

Billings, Montana, United States

Deaconess Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Internal Medicine Associates of Bozeman

Bozeman, Montana, United States

St. James Community Hospital

Butte, Montana, United States

Big Sky Oncology

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Sletten Regional Cancer Institute

Great Falls, Montana, United States

St. Peter's Hospital

Helena, Montana, United States

Glacier Oncology, PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Eastern Montana Cancer Center

Miles City, Montana, United States

Community Medical Center

Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences 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

Good Samaritan Health Systems

Kearney, Nebraska, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Rutherford Hospital

Rutherfordton, North Carolina, United States

MedCentral - Mansfield Hospital

Mansfield, Ohio, United States

Salem Hospital Regional Cancer Center

Salem, Oregon, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Harrington Cancer Center

Amarillo, Texas, United States

Doctor's Hospital of Laredo

Laredo, Texas, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Danville Regional Medical Center

Danville, Virginia, United States

Auburn Regional Center for Cancer Care

Auburn, Washington, United States

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Providence Hospital

Centralia, Washington, United States

St. Francis Hospital

Federal Way, Washington, United States

Cancer Care Center at Skagit Valley Hospital

Mount 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

Group Health Central Hospital

Seattle, Washington, United States

Harborview Medical Center

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 Care Northwest - Spokane South

Spokane, Washington, United States

Allenmore Hospital

Tacoma, Washington, United States

CCOP - Northwest

Tacoma, Washington, United States

St. Joseph Medical Center at Franciscan Health System

Tacoma, Washington, United States

St. Clare Hospital

Tacoma, Washington, United States

Central Washington Hospital

Wenatchee, Washington, United States

Wenatchee Valley Clinic

Wenatchee, Washington, United States

Camden-Clark Memorial Hospital

Parkersburg, West Virginia, United States

Welch Cancer Center

Sheridan, Wyoming, United States

Countries

United States

References

Smith HO, Moon J, Wilczynski SP, Tiersten AD, Hannigan EV, Robinson WR, Rivkin SE, Anderson GL, Liu PY, Markman M. Southwest Oncology Group Trial S9912: intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. Gynecol Oncol. 2009 Aug;114(2):206-9. doi: 10.1016/j.ygyno.2009.04.023. Epub 2009 May 23.

Reference Type: RESULT

PMID: 19464730 (View on PubMed)

Other Identifiers

S9912

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067066

Identifier Type: -

Identifier Source: org_study_id