- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00114166
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.
PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
Primary
- Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
- Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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New Britain, Connecticut, Estados Unidos, 06050
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
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Delaware
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Lewes, Delaware, Estados Unidos, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
- Washington Cancer Institute at Washington Hospital Center
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Georgia
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Augusta, Georgia, Estados Unidos, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Aurora, Illinois, Estados Unidos, 60507
- Rush-Copley Cancer Care Center
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60612-7243
- University of Illinois Cancer Center
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Hinsdale, Illinois, Estados Unidos, 60521
- Hinsdale Hematology Oncology Associates
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Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Indiana
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Michigan City, Indiana, Estados Unidos, 46360
- Saint Anthony Memorial Health Centers
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70815
- Woman's Hospital
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Maryland
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Elkton, Maryland, Estados Unidos, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts-NEMC Cancer Center
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Estados Unidos, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Estados Unidos, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Estados Unidos, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, Estados Unidos, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, Estados Unidos, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Estados Unidos, 48154
- St. Mary Mercy Hospital
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Pontiac, Michigan, Estados Unidos, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Estados Unidos, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Royal Oak, Michigan, Estados Unidos, 48073
- William Beaumont Hospital - Royal Oak Campus
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Saginaw, Michigan, Estados Unidos, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, Estados Unidos, 48093
- St. John Macomb Hospital
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Cancer Clinic
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Louis, Missouri, Estados Unidos, 63110
- Saint Louis University Cancer Center
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Springfield, Missouri, Estados Unidos, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Estados Unidos, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Estados Unidos, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Estados Unidos, 68114
- Methodist Estabrook Cancer Center
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New Jersey
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Neptune, New Jersey, Estados Unidos, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
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Voorhees, New Jersey, Estados Unidos, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Brooklyn, New York, Estados Unidos, 11203
- Suny Downstate Medical Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Stony Brook, New York, Estados Unidos, 11794-9446
- Stony Brook University Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Akron, Ohio, Estados Unidos, 44307
- McDowell Cancer Center at Akron General Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Case Comprehensive Cancer Center
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Cleveland, Ohio, Estados Unidos, 44111
- Cleveland Clinic Cancer Center at Fairview Hospital
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Columbus, Ohio, Estados Unidos, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Estados Unidos, 43222
- Mount Carmel Health - West Hospital
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Mayfield Heights, Ohio, Estados Unidos, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Mentor, Ohio, Estados Unidos, 44060
- Lake/University Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Cancer Institute
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Tulsa, Oklahoma, Estados Unidos, 74104
- Cancer Care Associates - Midtown Tulsa
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, Estados Unidos, 19010
- Bryn Mawr Hospital
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Paoli, Pennsylvania, Estados Unidos, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Reading, Pennsylvania, Estados Unidos, 19612-6052
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
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Wynnewood, Pennsylvania, Estados Unidos, 19096
- CCOP - MainLine Health
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Wynnewood, Pennsylvania, Estados Unidos, 19096
- Lankenau Cancer Center at Lankenau Hospital
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Harrington Cancer Center
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Wisconsin
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic - Marshfield Center
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Rice Lake, Wisconsin, Estados Unidos, 54868
- Marshfield Clinic - Indianhead Center
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Weston, Wisconsin, Estados Unidos, 54476
- Marshfield Clinic - Weston Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
- Recurrent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion not in a previously irradiated field
Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
- Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel
Platinum-sensitive disease
- Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 40 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No sensory or motor neuropathy > grade 1
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior biologic or immunologic agents for the malignancy
- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
- No concurrent cytokines during the first course of study treatment
- No concurrent pegfilgrastim
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- Recovered from prior chemotherapy
- No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
- No prior topotecan
Endocrine therapy
- At least 1 week since prior hormonal therapy for the malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of marrow-bearing areas
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for the malignancy
- No prior anticancer therapy that would preclude study treatment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
|
|
Comparador Ativo: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Objective Tumor Response
Prazo: Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
|
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease. |
Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
|
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Prazo: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Reason Off Study Therapy
Prazo: study entry through end of study treatment, up to 5 years
|
study entry through end of study treatment, up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Thomas J. Herzog, MD, Herbert Irving Comprehensive Cancer Center
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias Genitais Femininas
- Doenças anexiais
- Doenças das Trompas de Falópio
- Neoplasias das Trompas de Falópio
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores da Topoisomerase
- Inibidores da Topoisomerase I
- Topotecano
Outros números de identificação do estudo
- GOG-0146Q
- CDR0000434848
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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