- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00480623
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
****Please Note: Dr.Howard Sandler's site will be open to accrual shortly, Dr. Sarantopoulos's site in San Antonio is open and recruiting patients.****
There were approximately 232,000 cases of prostate cancer diagnosed in the US in 2005. Most patients present with localized disease and undergo curative therapy, either radical prostatectomy (RP) or radiation therapy (RT). Although most men are cured after this therapy, approximately 30,000-50,000 annually in the US will develop recurrence after RP. For most of these patients, recurrence will be defined by biochemical recurrence (BCR), a rise in PSA with no other documented evidence of recurrence. Patients with BCR typically receive radiation therapy to the prostate bed. However, about 50% of these patients will develop distant recurrence outside of the pelvis and require systemic therapy.
Satraplatin is a third generation orally administered platinum compound. Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer. Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study (The SPARC trial)as a single agent as second line therapy.
Tipo de estudo
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center at Dallas
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San Antonio, Texas, Estados Unidos, 78230
- The University of Texas Health Science Center at San Antonio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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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:
- Over or equal to 18 years of age.
- ECOG performance status less than or equal to 1
- Adequate organ function.
- History of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
- PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes patients whose PSA never becomes detectable. PSA progression must be measured by two consecutive samples, each separated by over or equal to 7 days. The PSA values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.
Exclusion Criteria:
- Known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive Prostascint scan will not be excluded)
- Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy.
- Lack of physical integrity of the upper GI tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including Crohn's disease and ulcerative colitis.
- Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered investigational (utilized for non-FDA approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Determine maximum tolerated dose and dose limiting toxicity for the combination of Satraplatin and radiation therapy.
Prazo: Serum chemistry and CBC will be evaluated weekly. PSA level will be evaluated on Day on of week 5.
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Serum chemistry and CBC will be evaluated weekly. PSA level will be evaluated on Day on of week 5.
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
PSA Response, Time to PSA Response, Duration of PSA response, Secondary Biochemical Recurrence Free Survival, Time to Biochemical Recurrence, Effect of Satraplatin on Serum Testosterone Levels, Safety and Tolerability.
Prazo: PSA level will be evaluated on Day on of week 5. There will be an end of treatment visit within 30 days of the last RT-Satraplatin treatment. PSA will be drawn every 3 m for 2 years, then every 6 m until evidence of either PSA or clinical progression.
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PSA level will be evaluated on Day on of week 5. There will be an end of treatment visit within 30 days of the last RT-Satraplatin treatment. PSA will be drawn every 3 m for 2 years, then every 6 m until evidence of either PSA or clinical progression.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Howard Sandler, MD, University of Michigan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (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 (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
- SAT1-06-01
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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