- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00448734
A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer
A Phase 1/2 Study of Picoplatin and Docetaxel (With Prednisone) in Subjects With Chemotherapy-Naive Metastatic Hormone-Refractory Prostate Cancer
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Chelyabinsk, Federação Russa, 454087
- Chelyabinsk Regional Oncology Center
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Moscow, Federação Russa, 105229
- Burdenko Central Military Clinical Hospital
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Moscow, Federação Russa, 117997
- Russian Research Center of Radiology
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Moscow, Federação Russa
- Research Institute of Urology - Ministry of Health
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St. Petersburg, Federação Russa, 188663
- Leningrad Regional Oncology Center
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St. Petersburg, Federação Russa, 194291
- Central Medical Unit #122
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St. Petersburg, Federação Russa, 194354
- Therapeutic and Research Medical Center
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St. Petersburg, Federação Russa, 196247
- St. Petersburg City Hospital #26
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St. Petersburg, Federação Russa, 198255
- St. Petersburg City Oncology Center
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Yaroslavl, Federação Russa, 150054
- State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital
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Kaluga Region
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Obninsk, Kaluga Region, Federação Russa, 249036
- Medical Radiology Research Center under the Russian Academy of Medical Sciences
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Radiologic evidence of metastatic disease (Jewett-Whitmore Stages D1-D2 or TNM Stage N1-3 or M1).
- Disease progression or recurrence documented by either: increasing serum PSA on three consecutive measurements each obtained at least one week apart, or findings on radiographic imaging studies.
- Non-surgically castrate subjects must be receiving androgen ablation therapy as maintenance therapy.
- Adequate hormonal therapy as documented by a castrate level of serum testosterone (all subjects without surgical castration must have a serum testosterone less than 50 ng/ml).
- At least 4 weeks must have elapsed after the withdrawal of antiandrogens (6 weeks in the case of bicalutamide).
- Age 18 years and over. Subjects older than 80 years should be entered on study only if considered "physiologically appropriate" for combination chemotherapy.
- ECOG performance score (PS) of 0 or 1.
- Stable levels of pain for at least 7 days before study entry.
- Life expectancy more than 3 months.
- At least 28 days must have elapsed since prior radiotherapy.
- At least 28 days must have elapsed since any prior investigational agent.
- Absolute neutrophil count (ANC) at least 1.5 x 10^9th/L.
- Platelet count at least 100 x 10^9th/L.
- Hemoglobin at least 10 g/dL.
- Serum AST and ALT levels ≥ 1.5 times upper limit of normal (ULN).
- Serum bilirubin ≤ ULN.
- Serum creatinine ≤ ULN.
- All subjects must agree to use appropriate birth control methods while on study and until 1 month after completion of study chemotherapy.
Exclusion Criteria:
- Prior treatment with cytotoxic agents (except estramustine), radioisotopes, or biological therapies other than hormones.
- Clinical evidence of brain or leptomeningeal metastases.
- Symptomatic peripheral neuropathy of Grade 2 or higher.
- History of another cancer within the preceding 5 years, except for superficial skin cancers.
- Known hypersensitivity to drugs formulated with Polysorbate 80.
- Prior radiotherapy that included ≥ 30% of the bone marrow (e.g., the whole of the pelvis or half of the spine).
- Uncontrolled intercurrent illness (e.g., active infection).
- Serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol.
- History of serious cardiac disease, defined as myocardial infarction within six months of enrollment, congestive heart failure classified by the New York Heart Association as Class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 1
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion. |
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion. |
Comparador Ativo: 2
Docetaxel
|
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
In Part 1, the Maximum Tolerated Dose (MTD) will be determined
Prazo: MTD
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MTD
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In Part 2, PSA response will be measured (reduction of at least 50% of PSA from baseline, with reduction maintained for at least 4 weeks)
Prazo: response
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response
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Progression free survival
Prazo: progression
|
progression
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Robert Earhart, MD, Poniard Pharmaceuticals
Publicações e links úteis
Publicações Gerais
- Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
- Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.
- Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.
- Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.
- Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
- Gelmon KA, Stewart D, Chi KN, Chia S, Cripps C, Huan S, Janke S, Ayers D, Fry D, Shabbits JA, Walsh W, McIntosh L, Seymour LK. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol. 2004 Jul;15(7):1115-22. doi: 10.1093/annonc/mdh278.
- Canobbio L, Guarneri D, Miglietta L, Decensi A, Oneto F, Boccardo F. Carboplatin in advanced hormone refractory prostatic cancer patients. Eur J Cancer. 1993;29A(15):2094-6. doi: 10.1016/0959-8049(93)90040-m.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Outros números de identificação do estudo
- 0502
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