- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00006812
Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal 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 capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.
- Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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 6-12 months.
Tipo di studio
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stati Uniti, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center
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Colorado
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Denver, Colorado, Stati Uniti, 80010
- University of Colorado Cancer Center
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Florida
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Tampa, Florida, Stati Uniti, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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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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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202-5289
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892
- Radiation Oncology Branch
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Tufts University School of Medicine
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Worcester, Massachusetts, Stati Uniti, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Missouri
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Columbia, Missouri, Stati Uniti, 65203
- Ellis Fischel Cancer Center - Columbia
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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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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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Stony Brook, New York, Stati Uniti, 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, 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 at Wake Forest University
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stati Uniti, 43210-1240
- 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, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Texas
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Houston, Texas, Stati Uniti, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
- Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer
Measurable disease
- At least 1 unidimensionally measurable lesion
- Ascites and pleural effusions are not considered measurable disease
Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
- Treatment-free interval of 6-12 months after response to platinum therapy
- Not eligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- 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 clearance at least 50 mL/min
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No neuropathy (sensory and motor) greater than grade 1
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No concurrent active infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic or immunologic therapy
- No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
- See Disease Characteristics
- If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed
- No prior capecitabine or fluorouracil
- No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens
- Recovered from prior chemotherapy
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 site(s) of measurable disease
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- Recovered from prior surgery
Other:
- No prior cancer treatment that would preclude study therapy
- No concurrent amifostine or other protective reagents
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Agustin Garcia, MD, University of Southern California
Pubblicazioni e link utili
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000068330
- GOG-0146L
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 .
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