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Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer

8. juli 2013 oppdatert av: Gynecologic Oncology Group

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.

Studieoversikt

Status

Fullført

Forhold

Eggstokkreft

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

470

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35294
    - University of Alabama Comprehensive Cancer Center
- Arizona
  - Phoenix, Arizona, Forente stater, 85006-2726
    - CCOP - Greater Phoenix
- California
  - Los Angeles, California, Forente stater, 90033-0800
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles, California, Forente stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Orange, California, Forente stater, 92868
    - Chao Family Comprehensive Cancer Center
  - Palo Alto, California, Forente stater, 94304
    - Women's Cancer Center
  - Stanford, California, Forente stater, 94305-5408
    - Stanford University Medical Center
- Colorado
  - Denver, Colorado, Forente stater, 80262
    - University of Colorado Cancer Center
- District of Columbia
  - Washington, District of Columbia, Forente stater, 20307-5000
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, Forente stater, 20007
    - Lombardi Cancer Center, Georgetown University
- Florida
  - Tampa, Florida, Forente stater, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, Forente stater, 30322
    - Emory University Hospital - Atlanta
- Hawaii
  - Honolulu, Hawaii, Forente stater, 96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago, Illinois, Forente stater, 60612
    - Rush-Presbyterian-St. Luke's Medical Center
- Indiana
  - Indianapolis, Indiana, Forente stater, 46202-5265
    - Indiana University Cancer Center
- Iowa
  - Iowa City, Iowa, Forente stater, 52242
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Lexington, Kentucky, Forente stater, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
- Maryland
  - Baltimore, Maryland, Forente stater, 21231
    - Johns Hopkins Oncology Center
- Massachusetts
  - Worcester, Massachusetts, Forente stater, 01655
    - University of Massachusetts Memorial Medical Center
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, Forente stater, 48201
    - Barbara Ann Karmanos Cancer Institute
- Minnesota
  - Minneapolis, Minnesota, Forente stater, 55455
    - University of Minnesota Cancer Center
- Mississippi
  - Jackson, Mississippi, Forente stater, 39216-4505
    - University of Mississippi Medical Center
- Missouri
  - Saint Louis, Missouri, Forente stater, 63110
    - Washington University School of Medicine
- New Jersey
  - Camden, New Jersey, Forente stater, 08103
    - Cooper Hospital/University Medical Center
  - Morristown, New Jersey, Forente stater, 07962-1956
    - Morristown Memorial Hospital
- New York
  - Albany, New York, Forente stater, 12208
    - Cancer Center of Albany Medical Center
  - Brooklyn, New York, Forente stater, 11203
    - State University of New York Health Science Center at Brooklyn
  - Manhasset, New York, Forente stater, 11030
    - North Shore University Hospital
  - New York, New York, Forente stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - Rochester, New York, Forente stater, 14642
    - University of Rochester Cancer Center
  - Stony Brook, New York, Forente stater, 11790-7775
    - State University of New York Health Sciences Center - Stony Brook
- North Carolina
  - Chapel Hill, North Carolina, Forente stater, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Durham, North Carolina, Forente stater, 27710
    - Duke Comprehensive Cancer Center
  - Winston-Salem, North Carolina, Forente stater, 27157-1082
    - Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Ohio
  - Cincinnati, Ohio, Forente stater, 45219
    - Barrett Cancer Center, The University Hospital
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forente stater, 44106-5065
    - Ireland Cancer Center
  - Columbus, Ohio, Forente stater, 43210
    - Arthur G. James Cancer Hospital - Ohio State University
- Oklahoma
  - Oklahoma City, Oklahoma, Forente stater, 73190
    - University of Oklahoma College of Medicine
- Oregon
  - Portland, Oregon, Forente stater, 97213
    - CCOP - Columbia River Program
- Pennsylvania
  - Abington, Pennsylvania, Forente stater, 19001
    - Abington Memorial Hospital
  - Hershey, Pennsylvania, Forente stater, 17033
    - Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forente stater, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, Forente stater, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, Forente stater, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- South Carolina
  - Charleston, South Carolina, Forente stater, 29425-0721
    - Medical University of South Carolina
  - Spartanburg, South Carolina, Forente stater, 29303
    - CCOP - Upstate Carolina
- Tennessee
  - Memphis, Tennessee, Forente stater, 38117
    - CCOP - Baptist Cancer Institute
  - Nashville, Tennessee, Forente stater, 37203
    - Brookview Research, Inc.
- Texas
  - Dallas, Texas, Forente stater, 75235-9154
    - Simmons Cancer Center - Dallas
  - Houston, Texas, Forente stater, 77030-4009
    - University of Texas - MD Anderson Cancer Center
- Virginia
  - Charlottesville, Virginia, Forente stater, 22908
    - Cancer Center, University of Virginia HSC
- Washington
  - Seattle, Washington, Forente stater, 98195-6043
    - University of Washington Medical Center
  - Tacoma, Washington, Forente stater, 98405
    - Tacoma General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gynecologic Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Peter G. Rose, MD, The Cleveland Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 1994

Primær fullføring (Faktiske)

1. desember 2004

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

4. mai 2004

Først lagt ut (Anslag)

5. mai 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. juli 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2013

Sist bekreftet

1. mai 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000063600
GOG-152

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .