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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002717
Other study ID # CDR0000064554
Secondary ID GOG-0162
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated May 24, 2013
Start date March 1996

Study information

Verified date January 2010
Source Gynecologic 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer.


Description:

OBJECTIVES: I. Compare progression free and overall survival and frequency of response in patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin. II. Determine the incidence and severity of adverse events, including catheter complications and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and measurable disease (yes vs no). Patients are randomized into one of two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6 courses.

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.


Recruitment information / eligibility

Status Completed
Enrollment 324
Est. completion date
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or primary peritoneal cancer Suboptimal residual disease within 6 weeks of laparotomy with maximum resection Stage III residual retroperitoneal disease greater than 1 cm and no greater than 1 cm residual intraperitoneal disease OR Stage IV disease The following histologies are eligible: Serous adenocarcinoma Malignant Brenner's tumor Mucinous adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Measurable disease not required Cytologic confirmation of malignant pleural effusion required if sole basis of entry No borderline (low malignant potential) carcinoma No unclassified ovarian cancer, i.e., thought to be of ovarian origin but unexplored or unable to verify tumor arising from ovarian stroma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST, ALT, and GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal LDH no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No history of congestive heart failure No history of unstable angina No myocardial infarction within 6 months Other: No severe infection, including septicemia No severe gastrointestinal bleeding No history of second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging laparotomy and primary cytoreductive surgery

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Intervention

Drug:
cisplatin

paclitaxel


Locations

Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States Cancer Center of Albany Medical Center Albany New York
United States CCOP - Ann Arbor Regional Ann Arbor Michigan
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Johns Hopkins Oncology Center Baltimore Maryland
United States University of Alabama Comprehensive Cancer Center Birmingham Alabama
United States State University of New York Health Science Center at Brooklyn Brooklyn New York
United States Cooper Hospital/University Medical Center Camden New Jersey
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Cancer Center, University of Virginia HSC Charlottesville Virginia
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Cleveland Clinic Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States Simmons Cancer Center - Dallas Dallas Texas
United States CCOP - Central Illinois Decatur Illinois
United States University of Colorado Cancer Center Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States MBCCOP - Hawaii Honolulu Hawaii
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Indiana University Cancer Center Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States CCOP - Kansas City Kansas City Missouri
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States CCOP - Baptist Cancer Institute Memphis Tennessee
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Memorial Sloan-Kettering Cancer Center New York New York
United States University of Oklahoma College of Medicine Oklahoma City Oklahoma
United States Chao Family Comprehensive Cancer Center Orange California
United States Women's Cancer Center Palo Alto California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States University of Rochester Cancer Center Rochester New York
United States Washington University School of Medicine Saint Louis Missouri
United States University of Washington Medical Center Seattle Washington
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Tacoma General Hospital Tacoma Washington
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Vincent T. Lombardi Cancer Research Center, Georgetown University Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (5)

Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482. — View Citation

Spriggs DR, Brady M, Rubin S, et al.: A phase III randomized trial of cisplatin and paclitaxel administered by either 24 hour or 96 hour infusion in patients with selected stage III or stage IV epithelial ovarian cancer (GOG162). [Abstract] J Clin Oncol 2

Spriggs DR, Brady MF, Vaccarello L, Clarke-Pearson DL, Burger RA, Mannel R, Boggess JF, Lee RB, Hanly M. Phase III randomized trial of intravenous cisplatin plus a 24- or 96-hour infusion of paclitaxel in epithelial ovarian cancer: a Gynecologic Oncology — View Citation

Winter WE 3rd, Maxwell GL, Tian C, Sundborg MJ, Rose GS, Rose PG, Rubin SC, Muggia F, McGuire WP; Gynecologic Oncology Group. Tumor residual after surgical cytoreduction in prediction of clinical outcome in stage IV epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2008 Jan 1;26(1):83-9. Epub 2007 Nov 19. — View Citation

Zorn KK, Tian C, McGuire WP, Hoskins WJ, Markman M, Muggia FM, Rose PG, Ozols RF, Spriggs D, Armstrong DK. The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer. 2009 Mar 1;115(5):1028-35. doi: 10.1002/cncr.24084. — View Citation

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