- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama Comprehensive Cancer Center
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California
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Los Angeles, California, Stati Uniti, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Stati Uniti, 94304
- Women's Cancer Center
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Colorado
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Denver, Colorado, Stati Uniti, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Stati Uniti, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa, Florida, Stati Uniti, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago Cancer Research Center
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Decatur, Illinois, Stati Uniti, 62526
- CCOP - Central Illinois
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202-5265
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Worcester, Massachusetts, Stati Uniti, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Stati Uniti, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota Cancer Center
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, Stati Uniti, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, Stati Uniti, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Stati Uniti, 11203
- State University of New York Health Science Center at Brooklyn
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New York, New York, Stati Uniti, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, Stati Uniti, 14642
- University of Rochester Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Stati Uniti, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Cancer Center
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Cleveland, Ohio, Stati Uniti, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Stati Uniti, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, Stati Uniti, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, Stati Uniti, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Pennsylvania Hospital
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425-0721
- Medical University of South Carolina
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Spartanburg, South Carolina, Stati Uniti, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38117
- CCOP - Baptist Cancer Institute
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Texas
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Dallas, Texas, Stati Uniti, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, Stati Uniti, 77030
- University of Texas - MD Anderson Cancer Center
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, Stati Uniti, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, Stati Uniti, 98405
- Tacoma General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- carcinoma epiteliale ovarico in stadio III
- carcinoma epiteliale ovarico in stadio IV
- carcinoma primitivo della cavità peritoneale
- cistoadenocarcinoma sieroso ovarico
- Adenocarcinoma ovarico indifferenziato
- cistoadenocarcinoma ovarico a cellule chiare
- Adenocarcinoma endometrioide ovarico
- Cistoadenocarcinoma mucinoso ovarico
- carcinoma epiteliale misto ovarico
- Tumore del Brennero
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie genitali, femmina
- Malattie del sistema endocrino
- Malattie ovariche
- Malattie annessiali
- Disturbi gonadici
- Neoplasie delle ghiandole endocrine
- Neoplasie ovariche
- Carcinoma, epiteliale ovarico
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Paclitaxel
- Cisplatino
Altri numeri di identificazione dello studio
- CDR0000064554
- GOG-0162
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro ovarico
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
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National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
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Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
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NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
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Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
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Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
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Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutanteStadio III Adenocarcinoma della prostata AJCC v7 | Stadio II Adenocarcinoma prostatico AJCC v7 | Fase I Adenocarcinoma della prostata American Joint Committee on Cancer (AJCC) v7Stati Uniti
Prove cliniche su cisplatino
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Korea Cancer Center HospitalCompletatoNEOPLASMI CERVICALICorea, Repubblica di
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Ruhr University of BochumCompletatoCancro ovarico ricorrenteGermania