- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002717
Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama Comprehensive Cancer Center
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California
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Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, United States, 94304
- Women's Cancer Center
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, United States, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, United States, 60637
- University of Chicago Cancer Research Center
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Indiana
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Indianapolis, Indiana, United States, 46202-5265
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, United States, 11203
- State University of New York Health Science Center at Brooklyn
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, United States, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, United States, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, United States, 38117
- CCOP - Baptist Cancer Institute
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, United States, 77030
- University of Texas - MD Anderson Cancer Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, United States, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, United States, 98405
- Tacoma General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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. doi: 10.1200/JCO.2007.13.1953. Epub 2007 Nov 19.
- 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 Group Study. J Clin Oncol. 2007 Oct 1;25(28):4466-71. doi: 10.1200/JCO.2006.10.3846.
- 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 22 (Suppl 14): A-5004, 450s, 2004.
- Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086. Erratum In: Obstet Gynecol. 2019 Apr;133(4):830.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- primary peritoneal cavity cancer
- ovarian serous cystadenocarcinoma
- ovarian undifferentiated adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian mixed epithelial carcinoma
- Brenner tumor
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- CDR0000064554
- GOG-0162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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