Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer
A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN 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 or combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.
OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875. Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol; CDDP.
PROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University Of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Spojené státy, 85006-2726
- CCOP - Greater Phoenix
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California
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Los Angeles, California, Spojené státy, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Spojené státy, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, Spojené státy, 92868
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Spojené státy, 94304
- Women's Cancer Center
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Stanford, California, Spojené státy, 94305-5408
- Stanford University Medical Center
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Colorado
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Denver, Colorado, Spojené státy, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Spojené státy, 20007
- Lombardi Cancer Center, Georgetown University
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Florida
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Tampa, Florida, Spojené státy, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, Spojené státy, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202-5265
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, Spojené státy, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Spojené státy, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, Spojené státy, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Worcester, Massachusetts, Spojené státy, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Spojené státy, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
- University of Minnesota Cancer Center
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Mississippi
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Jackson, Mississippi, Spojené státy, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, Spojené státy, 08103
- Cooper Hospital/University Medical Center
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Morristown, New Jersey, Spojené státy, 07962-1956
- Morristown Memorial Hospital
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New York
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Albany, New York, Spojené státy, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Spojené státy, 11203
- State University of New York Health Science Center at Brooklyn
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Manhasset, New York, Spojené státy, 11030
- North Shore University Hospital
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New York, New York, Spojené státy, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, Spojené státy, 14642
- University of Rochester Cancer Center
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Stony Brook, New York, Spojené státy, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Spojené státy, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Spojené státy, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Spojené státy, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Spojené státy, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73190
- University of Oklahoma College of Medicine
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Oregon
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Portland, Oregon, Spojené státy, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Abington, Pennsylvania, Spojené státy, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, Spojené státy, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Spojené státy, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425-0721
- Medical University of South Carolina
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Spartanburg, South Carolina, Spojené státy, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, Spojené státy, 38117
- CCOP - Baptist Cancer Institute
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Nashville, Tennessee, Spojené státy, 37203
- Brookview Research, Inc.
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Texas
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Dallas, Texas, Spojené státy, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, Spojené státy, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, Spojené státy, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, Spojené státy, 98405
- Tacoma General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136
PATIENT CHARACTERISTICS: Age: Any age 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 more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients
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 surgery
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Peter G. Rose, MD, The Cleveland Clinic
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- von Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022.
- Winter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7. doi: 10.1200/JCO.2006.10.2517.
- van der Burg ME, Vergote I; Gynecological Cancer Group of the EORTC. The role of interval debulking surgery in ovarian cancer. Curr Oncol Rep. 2003 Nov;5(6):473-81. doi: 10.1007/s11912-003-0008-8.
- Wenzel L, Huang HQ, Monk BJ, Rose PG, Cella D. Quality-of-life comparisons in a randomized trial of interval secondary cytoreduction in advanced ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2005 Aug 20;23(24):5605-12. doi: 10.1200/JCO.2005.08.147.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CDR0000063600
- GOG-152
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