- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00028912
Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Phase I Trial of Bortezomib (NSC 681239, IND#58443) and Carboplatin in Recurrent or Progressive Epithelial Ovarian Cancer or Primary Peritoneal Cancer
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may help carboplatin kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin in treating patients who have recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the maximum tolerated dose of bortezomib in combination with carboplatin in patients with recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacodynamics of this regimen in these patients by measurement of 20S proteasome inhibition in whole blood.
- Correlate toxicity with 20S proteasome inhibition in a whole blood assay in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive carboplatin IV over 30 minutes on days 1 and 8 followed by 1 week of rest during the first course of treatment. Beginning with the second course, patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 8 additional patients are accrued and treated at that dose.
PROJECTED ACCRUAL: A total of 3-32 patients will be accrued for this study.
Tipo de estudo
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Recurrent or progressive disease
Received at least 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
- May include high-dose therapy, consolidation, or extended therapy after surgical or non-surgical assessment
- No brain metastases or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- AST and ALT no greater than 2.5 times upper limit of normal
- Bilirubin no greater than 1.8 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- LVEF greater than 50% by radionuclide ventriculogram or two-dimensional echocardiogram
- No peripheral vascular disease requiring surgical management
- No prior myocardial infarction
- No congestive heart failure
- No orthostatic hypotension
- No acute ischemia or significant conduction abnormality (bifascicular block, defined as left anterior hemiblock with right bundle branch block, second or third degree AV blocks) as evidenced by electrocardiogram
- No prior cerebrovascular event
Other:
- No peripheral neuropathy grade 2 or greater
- No other serious medical or psychiatric illness
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No more than 2 prior regimens for recurrent disease, including 1 non-platinum containing regimen
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
Endocrine therapy:
- At least 1 week since prior hormonal therapy directed at primary tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior major surgery
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center
Publicações e links úteis
Publicações Gerais
- Aghajanian C, Dizon DS, Sabbatini P, Raizer JJ, Dupont J, Spriggs DR. Phase I trial of bortezomib and carboplatin in recurrent ovarian or primary peritoneal cancer. J Clin Oncol. 2005 Sep 1;23(25):5943-9. doi: 10.1200/JCO.2005.16.006.
- Aghajanian C, Dizon D, Yan XJ, et al.: Phase I trial of PS-341 and carboplatin in recurrent ovarian cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1815, 2003.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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 por Tipo Histológico
- Neoplasias
- Neoplasias urogenitais
- Neoplasias por local
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias Genitais Femininas
- Doenças do Sistema Endócrino
- Doenças ovarianas
- Doenças anexiais
- Distúrbios Gonadais
- Neoplasias das Glândulas Endócrinas
- Doenças das Trompas de Falópio
- Neoplasias ovarianas
- Neoplasias das Trompas de Falópio
- Carcinoma Epitelial Ovariano
- Agentes Antineoplásicos
- Carboplatina
- Bortezomibe
Outros números de identificação do estudo
- CDR0000069146
- MSKCC-01097
- NCI-5326
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