- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Alberta
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Calgary, Alberta, Kanada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Alabama
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Birmingham, Alabama, Spojené státy, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Los Angeles, California, Spojené státy, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Spojené státy, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Orange, California, Spojené státy, 92868
- Chao Family Comprehensive Cancer Center
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Colorado
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Denver, Colorado, Spojené státy, 80010
- University of Colorado Cancer Center
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Florida
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Tampa, Florida, Spojené státy, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202-5289
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, Spojené státy, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- Radiation Oncology Branch
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02111
- Tufts University School of Medicine
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Worcester, Massachusetts, Spojené státy, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Missouri
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Columbia, Missouri, Spojené státy, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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New Jersey
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Camden, New Jersey, Spojené státy, 08103
- Cooper Hospital/University Medical Center
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New York
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Brooklyn, New York, Spojené státy, 11203
- State University of New York Health Science Center at Brooklyn
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New York, New York, Spojené státy, 10021
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, Spojené státy, 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, Spojené státy, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Spojené státy, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Spojené státy, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Spojené státy, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, Spojené státy, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, Spojené státy, 17033
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Spojené státy, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Texas
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Houston, Texas, Spojené státy, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Agustin Garcia, MD, University of Southern California
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CDR0000068330
- GOG-0146L
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