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Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy

20. juni 2013 oppdatert av: Gynecologic Oncology Group

Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Legemiddel: oksaliplatin

Detaljert beskrivelse

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory, platinum resistant ovarian epithelial or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.

Studietype

Intervensjonell

Fase

Fase 2

Kontakter og plasseringer

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

Studiesteder

Canada
- Ontario
  - Kingston, Ontario, Canada, K7L 3N6
    - NCIC-Clinical Trials Group
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
- 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
    - Vincent T. Lombardi Cancer Research 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, 60612-7323
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, Forente stater, 60612
    - Rush-Presbyterian-St. Luke's Medical Center
  - Chicago, Illinois, Forente stater, 60637
    - University of Chicago Cancer Research Center
  - Evanston, Illinois, Forente stater, 60201
    - CCOP - Evanston
  - Springfield, Illinois, Forente stater, 62526
    - CCOP - Central Illinois
- Indiana
  - Indianapolis, Indiana, Forente stater, 46202-5265
    - Indiana University Cancer Center
- Iowa
  - Des Moines, Iowa, Forente stater, 10309-1016
    - CCOP - Iowa Oncology Research Association
  - 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, 21287
    - Johns Hopkins Oncology Center
  - Bethesda, Maryland, Forente stater, 20892
    - Radiation Oncology Branch
  - Bethesda, Maryland, Forente stater, 20892
    - Medicine Branch
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02111
    - Tufts University School of Medicine
  - 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
  - Keesler AFB, Mississippi, Forente stater, 39534-2576
    - Keesler Medical Center - Keesler AFB
- Missouri
  - Columbia, Missouri, Forente stater, 65203
    - Ellis Fischel Cancer Center
  - Kansas City, Missouri, Forente stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forente stater, 63110
    - Washington University School of Medicine
  - Springfield, Missouri, Forente stater, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, Forente stater, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, Forente stater, 68131
    - CCOP - Missouri Valley Cancer Consortium
- Nevada
  - Las Vegas, Nevada, Forente stater, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Jersey
  - Camden, New Jersey, Forente stater, 08103
    - Cooper Hospital/University Medical Center
- 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, 11790-9832
    - 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
  - Winston-Salem, North Carolina, Forente stater, 27103
    - Brookview Research, Inc.
- Ohio
  - Cincinnati, Ohio, Forente stater, 45219
    - Barrett Cancer Center, The University Hospital
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic 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
  - Tulsa, Oklahoma, Forente stater, 74136
    - CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
- 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, 19107
    - Pennsylvania Hospital
  - Philadelphia, Pennsylvania, Forente stater, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, Forente stater, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Wynnewood, Pennsylvania, Forente stater, 19096
    - CCOP - MainLine Health
- South Carolina
  - Charleston, South Carolina, Forente stater, 29425-0721
    - Medical University of South Carolina
  - Greenville, South Carolina, Forente stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forente stater, 29303
    - CCOP - Upstate Carolina
- Tennessee
  - Memphis, Tennessee, Forente stater, 38117
    - CCOP - Baptist Cancer Institute
- Texas
  - Dallas, Texas, Forente stater, 75235-9154
    - Simmons Cancer Center - Dallas
  - Houston, Texas, Forente stater, 77030
    - University of Texas - MD Anderson Cancer Center
  - Temple, Texas, Forente stater, 76508
    - CCOP - Scott and White Hospital
- 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 recurrent or refractory ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and pleural effusions are not considered measurable disease Sonography acceptable provided lesions are clearly defined on initial examination and bidimensionally measurable Must have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease Initial treatment may include high dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens Must be considered platinum resistant or refractory Treatment free interval of less than 6 months following platinum or progression during platinum based therapy No known brain metastases Must not be eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater than grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignant tumor Concurrent continuation of hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling

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: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center

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. februar 2000

Studiet fullført (Faktiske)

1. juli 2004

Datoer for studieregistrering

Først innsendt

2. juni 2000

Først innsendt som oppfylte QC-kriteriene

28. april 2003

Først lagt ut (Anslag)

29. april 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juni 2013

Sist bekreftet

1. mars 2003

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000067851
GOG-126K

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. .