- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00005836
Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
- NCIC-Clinical Trials Group
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- University of Alabama Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, États-Unis, 85006-2726
- CCOP - Greater Phoenix
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California
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Los Angeles, California, États-Unis, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, États-Unis, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Orange, California, États-Unis, 92868
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, États-Unis, 94304
- Women's Cancer Center
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Colorado
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Denver, Colorado, États-Unis, 80262
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, États-Unis, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, États-Unis, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Tampa, Florida, États-Unis, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- MBCCOP - Hawaii
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Illinois
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Chicago, Illinois, États-Unis, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, États-Unis, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, États-Unis, 60637
- University of Chicago Cancer Research Center
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Evanston, Illinois, États-Unis, 60201
- CCOP - Evanston
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Springfield, Illinois, États-Unis, 62526
- CCOP - Central Illinois
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Indiana
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Indianapolis, Indiana, États-Unis, 46202-5265
- Indiana University Cancer Center
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Iowa
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Des Moines, Iowa, États-Unis, 10309-1016
- CCOP - Iowa Oncology Research Association
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Iowa City, Iowa, États-Unis, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, États-Unis, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins Oncology Center
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Bethesda, Maryland, États-Unis, 20892
- Radiation Oncology Branch
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Bethesda, Maryland, États-Unis, 20892
- Medicine Branch
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Tufts University School of Medicine
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Worcester, Massachusetts, États-Unis, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, États-Unis, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota Cancer Center
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Mississippi
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Jackson, Mississippi, États-Unis, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, États-Unis, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia, Missouri, États-Unis, 65203
- Ellis Fischel Cancer Center
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Springfield, Missouri, États-Unis, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, États-Unis, 68131
- CCOP - Missouri Valley Cancer Consortium
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Nevada
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Las Vegas, Nevada, États-Unis, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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Camden, New Jersey, États-Unis, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, États-Unis, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, États-Unis, 11203
- State University of New York Health Science Center at Brooklyn
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital
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New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, États-Unis, 14642
- University of Rochester Cancer Center
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Stony Brook, New York, États-Unis, 11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, États-Unis, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, États-Unis, 27103
- Brookview Research, Inc.
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Cancer Center
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Cleveland, Ohio, États-Unis, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, États-Unis, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73190
- University of Oklahoma College of Medicine
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Tulsa, Oklahoma, États-Unis, 74136
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
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Oregon
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Portland, Oregon, États-Unis, 97213
- CCOP - Columbia River Program
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Pennsylvania
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Abington, Pennsylvania, États-Unis, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, États-Unis, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, États-Unis, 19107
- Pennsylvania Hospital
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, États-Unis, 19107
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Wynnewood, Pennsylvania, États-Unis, 19096
- CCOP - MainLine Health
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South Carolina
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Charleston, South Carolina, États-Unis, 29425-0721
- Medical University of South Carolina
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Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, États-Unis, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, États-Unis, 38117
- CCOP - Baptist Cancer Institute
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Texas
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Dallas, Texas, États-Unis, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, États-Unis, 77030
- University of Texas - MD Anderson Cancer Center
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Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- Cancer Center, University of Virginia HSC
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Washington
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Seattle, Washington, États-Unis, 98195-6043
- University of Washington Medical Center
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Tacoma, Washington, États-Unis, 98405
- Tacoma General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs génitales, femme
- Maladies du système endocrinien
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Tumeurs des glandes endocrines
- Tumeurs ovariennes
- Carcinome épithélial ovarien
- Agents antinéoplasiques
- Oxaliplatine
Autres numéros d'identification d'étude
- CDR0000067851
- GOG-126K
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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