- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01019798
Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer
Phase II Study of Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer
Sunitinib shows anti-tumor activity in a variety of human non-small cell lung tumor ex vivo models. Many Phases II and III clinical trials of sunitinib in several solid tumors are completed or still ongoing. So far, the efficacy of sunitinb has been confirmed by the phase III trial for imatinib-resistance or intolerance advanced gastrointestinal stromal tumor patients. And sutent was approved to effective by two phase II trials in advanced renal cell carcinoma patients after failure of immunotherapies, and one phase III trial in treatment-naive advanced renal carcinoma patients. Sunitinib (SUTENT ®) has been approved by U.S. Food and Drug Administration (FDA) for the treatment of advanced renal carcinoma patients and in gastrointestinal stromal tumor patients who are intolerant or progressed after imatinib mesylate. European Medicines Agency (EMEA) conditionally granted the marketing approval for the treatment of metastatic renal carcinoma patients after failure of immunotherapy.
A phase II trial (A6181040 study) on non-small cell lung cancer patients treated with sunitinib alone showed anti-tumor activity. In 63 enrolled patients treated with 4/2 schedule (4 weeks treatment, then two weeks interruption), 7 patients are confirmed partial response (overall response rate, 11%), and median progress-free time is 14.3 weeks. Presently, a phase III study is underway on non-small cell lung cancer patients followed by and now is under recruiting.
Non-small cell lung cancer cells often over-express vascular endothelial growth factor (VEGF) receptors. Besides, the expression of the VEGF ligands is also correlated with increased tumor angiogenesis, as well as shortened survival time. One study treated with VEGF-directed monoclonal antibody (bevacizumab) and VEGFR and platelet-derived growth factor receptor (PDGFR) small molecule inhibitors (sunitinib) showed that some non-small cell lung cancer patients are with anti-tumor activity.
The chemotherapy drugs, such as docetaxel and platinum-based compounds, were with evidence that they have direct cytotoxicity to cancer cells. Therefore, the investigators are paying attention to the efficacy of combining sunitinib and conventional chemotherapy in this study.
The study is designed as first line of salvage therapy on metastatic or unresectable non-small cell lung cancer patients. The main goals of this study is to evaluate the overall response rate (ORR) and duration of response (DR) of sunitinib in combinational with docetaxel and cisplatin in chemotherapy-naive advanced or metastatic non-small cell lung cancer patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Design This is a single-center, open-label, phase II clinical trial. Simon two-stage analysis is adopted.The sample size in the first stage is 16 patients. The length of study is approximately 24 months. The targeted subject is patient with metastatic or unresectable non-small cell lung cancer.
Study Endpoints Primary Endpoint Assess the response rate of sunitinib, docetaxel and cisplatin in the treatment of naïve chemotherapy metastatic or unresectable non-small cell lung cancer patients.
Secondary Endpoint
- Time to disease progression (defined as the time period from the start of investigated medication to investigator assessed disease progression) at the end of study.
- Duration of survival (defined as the time period from the start of investigated medication to death).
- Safety profile of sunitinib in combination with docetaxel and cisplatin: cardiac toxicity assessed in accordance with National Cancer Institute Common Toxicity Criteria (version 3.0). The incidence of serious adverse events related to the treatment and the incidence of specific adverse events (serious and non-serious) such as gastro-intestinal perforation, wound healing complication, bleeding, hypertension, arterial thromboembolic events and proteinuria will be investigated. NCI-CTCAE criteria (version 3.0) will be used.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Taipei, Taiwan, 110
- Recrutamento
- Section of Hematology, Department of Medicine,Taipei Medical University Hospital
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Contato:
- Cheng-Jeng Tai, M.D.
- Número de telefone: 3903 886-2-27372181
- E-mail: cjtai@tmu.edu.tw
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Investigador principal:
- Cheng-Jeng Tai, M.D.
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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:
- Male or female,18 years of age or older.
- Chemotherapy-naive patients with metastatic or unresectable non-small cell lung cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Normal left ventricular ejection fraction (LVEF).
- At least one unidimensionally measurable lesion with a diameter > 10 mm using CT scan.
- Life expectancy greater than 3 months.
- Neutrophils 1,500/L, Platelets 100,000/L, AST/ALT 2.5 ULN (< 5 ULN if liver metastases), Alkaline phosphatase 2.5 ULN, Serum bilirubin 1.5 ULN, Serum Creatinine 1.5 ULN.
- Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate 1g of protein/24 hr.
- Patients in this study should avoid having child. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first.
- Signed written informed consent according to ICH/GCP and the local regulations (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures.
- Patient must be able to comply with the protocol.
Exclusion Criteria:
- Poor condition and inappropriate situation to enter this study, which could be determined by the principle investigator or in-charge attending physician.
- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg).
- Prior exposure to VEGF inhibitors.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study.
- Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed).
- Clinical or radiological evidence of CNS metastases.
- Serious non-healing wound or ulcer.
- Evidence of bleeding diathesis or coagulopathy.
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six months.
- Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of potency of permanent indwelling IV catheters.
- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
- Ongoing treatment with large dose aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration (Continuous using NSAIDs).
- Pregnancy (positive serum pregnancy test) and lactation.
- Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
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)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: rótulo aberto
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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response rate by RECIST criteria
Prazo: every 3 months
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every 3 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Time to disease progression at the end of study
Prazo: monthly
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monthly
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Duration of survival
Prazo: monthly
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monthly
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Safety profile: cardiac toxicity assessed in accordance with National Cancer Institute Common Toxicity Criteria. NCI-CTCAE criteria (version 3.0) will be used.
Prazo: monthly
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monthly
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cheng-Jeng Tai, M.D., Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital
Publicações e links úteis
Publicações Gerais
- Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
- Mendel DB, Laird AD, Xin X, Louie SG, Christensen JG, Li G, Schreck RE, Abrams TJ, Ngai TJ, Lee LB, Murray LJ, Carver J, Chan E, Moss KG, Haznedar JO, Sukbuntherng J, Blake RA, Sun L, Tang C, Miller T, Shirazian S, McMahon G, Cherrington JM. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res. 2003 Jan;9(1):327-37.
- Socinski MA. Adjuvant therapy of resected non-small-cell lung cancer. Clin Lung Cancer. 2004 Nov;6(3):162-9. doi: 10.3816/CLC.2004.n.029.
- Papaetis GS, Syrigos KN. Sunitinib: a multitargeted receptor tyrosine kinase inhibitor in the era of molecular cancer therapies. BioDrugs. 2009;23(6):377-89. doi: 10.2165/11318860-000000000-00000.
- Swanton C, Burrell RA. Advances in personalized therapeutics in non-small cell lung cancer: 4q12 amplification, PDGFRA oncogene addiction and sunitinib sensitivity. Cancer Biol Ther. 2009 Nov;8(21):2051-3. doi: 10.4161/cbt.8.21.9886. No abstract available.
- Novello S, Scagliotti GV, Rosell R, Socinski MA, Brahmer J, Atkins J, Pallares C, Burgess R, Tye L, Selaru P, Wang E, Chao R, Govindan R. Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Br J Cancer. 2009 Nov 3;101(9):1543-8. doi: 10.1038/sj.bjc.6605346. Epub 2009 Oct 13.
- Pallis AG, Serfass L, Dziadziusko R, van Meerbeeck JP, Fennell D, Lacombe D, Welch J, Gridelli C. Targeted therapies in the treatment of advanced/metastatic NSCLC. Eur J Cancer. 2009 Sep;45(14):2473-87. doi: 10.1016/j.ejca.2009.06.005.
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
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Inibidores de proteína quinase
- Docetaxel
- Sunitinibe
Outros números de identificação do estudo
- CRC-01-08-03
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