S9912 Combination Chemo in Stage III Ovarian Cancer,

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003896
• Other study ID #: CDR0000067066
• Secondary ID: S9912U10CA032102
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 2, 2013
• Start date: September 1999
• Est. completion date: February 2008

Study information

• Verified date: January 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• cisplatin

• liposomal doxorubicin

• paclitaxel

Locations

Country	Name	City	State
United States	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois
United States	Harrington Cancer Center	Amarillo	Texas
United States	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	Cancer Care Center at Battle Creek Health System	Battle Creek	Michigan
United States	Bay Regional Medical Center	Bay City	Michigan
United States	St. Joseph Hospital Community Cancer Center	Bellingham	Washington
United States	Mecosta County General Hospital	Big Rapids	Michigan
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Deaconess Billings Clinic Cancer Center	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	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Internal Medicine Associates of Bozeman	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	St. James Community Hospital	Butte	Montana
United States	St. Francis Medical Center	Cape Girardeau	Missouri
United States	Providence Hospital	Centralia	Washington
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Danville Regional Medical Center	Danville	Virginia
United States	University of California Davis Cancer Center	Davis	California
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Breslin Cancer Center at Ingham Regional Medical Center	East Lansing	Michigan
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	St. Francis Hospital	Federal Way	Washington
United States	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Gape Girardeau	Missouri
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
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	Metropolitan Hospital	Grand Rapids	Michigan
United States	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan
United States	Spectrum Health Hospital - Blodgett Campus	Grand Rapids	Michigan
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	Saint Rose Hospital	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Holland Community Hospital	Holland	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Good Samaritan Health Systems	Kearney	Nebraska
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	Southwest Medical Center	Liberal	Kansas
United States	Valley Memorial Hospital	Livermore	California
United States	MedCentral - Mansfield Hospital	Mansfield	Ohio
United States	Eastern Montana Cancer Center	Miles City	Montana
United States	Community Medical Center	Missoula	Montana
United States	Judy L. Schmidt, MD, FACP, P. C.	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	Cancer Care Center at Skagit Valley Hospital	Mt. Vernon	Washington
United States	Good Samaritan Regional Health Center	Mt. Vernon	Illinois
United States	Hackley Hospital	Muskegon	Michigan
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital	Oakland	California
United States	Summit Medical Center	Oakland	California
United States	Capital Medical Center	Olympia	Washington
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Mercy Hospital	Port Huron	Michigan
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Salem Hospital Regional Cancer Center	Salem	Oregon
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	Salina Regional Health Center	Salina	Kansas
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	J.C. Robinson, M.D. Regional Cancer Center	San Pablo	California
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	Welch Cancer Center	Sheridan	Wyoming
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
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	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington
United States	Munson Medical Center	Traverse City	Michigan
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona
United States	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Central Washington Hospital	Wenatchee	Washington
United States	Wenatchee Valley Clinic	Wenatchee	Washington
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

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 doxorubic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall Survival	from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact	Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.	No
Secondary	Adverse Events	Only adverse events that are possibly, probably or definitely related to study drug are reported.	Weekly during 6 weeks of protocol treatment	Yes