Clinical Trial of Boanmycin Hydrochloride With Docetaxel for Patients With Lung Squamous Cell Cancer as Chemotherapy
21 de diciembre de 2015 actualizado por: Tianjin Medical University Cancer Institute and Hospital
Boanmycin Hydrochloride for Injection in Combination With Docetaxel for Patients With Advanced Lung Squamous Cell Carcinoma as Salvage Chemotherapy: a Prospective, Randomized, Parallel and Controlled Clinical Trial
This predictive, randomized, double-blind, multi-center trial is going to evaluate the efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous cell lung cancer patients.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
At present, there is no reliable second line treatment except chemotherapy for squamous cell carcinoma patients, the current chemotherapy regimen, including docetaxel as a single agent which is known as the gold standard, the weekly using of docetaxel and the combination of EGFR-TKI has few evidence for high response rates and prolonged survival.On the other hand, the adverse reaction of chemotherapy makes the combined chemotherapy cannot improve therapeutic effects. Boanmycin with special pharmacological basis, as well as the high purity, may not obvious increase in adverse reactions, and probably improve the effect of chemotherapy. At the same time, because of its low lung toxicity, especially in the combined use of corticosteroids, and in the background of the poor survival of advanced squamous cell lung cancer patients, the chemotherapy regimen of boanmycin plus docetaxel needs to be investigated.
This predictive, randomized, double-blind, multi-center trial is going to evaluate the efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous cell lung cancer patients.
According to the test center, gender, disease staging (stage IIIB, IV/recurrence) and pathologic types, patients with squamous cell lung cancer were stratified and then randomly assigned to one of two groups. In the first group, 75 mg of docetaxel per square meter of body-surface area, administered on day 1, followed by 5~6 mg boanmycin of per square meter and 5mg dexamethasone on days 3,5,10 and 12, the cycle was repeated every 21days. The second group received the reference treatment: docetaxel at a dose of 75 mg per square meter was administered on on day 1 of a three-week cycle. The efficacy was evaluated using RESIST standard after every 2 cycles of the treatment, the regimen will continue until the disease progression or the appearance of not tolerable toxicity.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
300
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Tianjin
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Tianjin, Tianjin, Porcelana, 300060
- Reclutamiento
- Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
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Investigador principal:
- Peng Chen, M.D.
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Contacto:
- Peng Chen, M.D.
- Número de teléfono: 3206 +86-22-23340123
- Correo electrónico: chenpengdoc@sina.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- histologically or cytology confirmed III，IV or after operation recurrent squamous cell lung cancer;
- disease progressed after first-line chemotherapy and not suitable for EGFR-TKI;
- no radiotherapy for metastases outside the lung 4 weeks before;
- the lesions are measurable in CT images and are measured follow criteria RECIST 1.1 2 weeks before randomization;
- ECOG scale 0-1, expected survival>3 month;
- white blood count ≥ 3,500/mm3, absolute neutrophil≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count≥ 90 g/dL；serum bilirubin level ≤ 1.5 of the upper limit of normal(ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase≤ 2.5 ULN, serum creatinine≤ 1.5 ULN;
- with good compliance；
Exclusion Criteria:
- past history of major operation in 4 weeks;
- involved in other clinical trials in 4 weeks;
- past history of central nervous system or relevant disease except for well-controlled CNS metastasis;
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
- concomitant treatment with other anticancer drugs.
- pregnancy, breast feeding or fertility but not taking contraceptive device during the trials;
- radiotherapy for target lesions in lung;
- clear TKI-related mutation in EGFR;
- with severe heart disease, hypertension, diabetes mellitus or active infection.
- past history of allergy to taxanes;
- past history of severe acute or chronic kidney disease;
- active hepatitis b or HIV positive patients;
- cannot tolerate Corticosteroid;
- past history of COPD or other critical basic pulmonary diseases;
- history of severe mental illness.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Docetaxel/Boanmycin
Docetaxel 75mg/m2, intravenous infusion, day 1; Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.
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Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.
Otros nombres:
Docetaxel 75mg/m2, intravenous infusion, day 1.
Otros nombres:
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Comparador de placebos: Docetaxel
Docetaxel 75mg/m2, intravenous infusion, day 1, 21days a cycle.
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Docetaxel 75mg/m2, intravenous infusion, day 1.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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disease free survival
Periodo de tiempo: 1.5 years
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DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
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1.5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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overall survival
Periodo de tiempo: 1.5 years
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OS was defined as the length of time from the date of randomization to the date of death of various reasons.
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1.5 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adverse Events
Periodo de tiempo: 1.5 years
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An Adverse Events is any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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1.5 years
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serious adverse event
Periodo de tiempo: 1.5 years
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SAE is medically significant or requires intervention to prevent one or other of the outcomes, such as: Fatal (results in death);Life-Threatening Hospitalization; prolong hospitalization; Anomaly/birth defect or Disability/incapacity.
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1.5 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Peng Chen, M.D., Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884. Erratum In: N Engl J Med. 2007 Jan 18;356(3):318.
- Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000 May;18(10):2095-103. doi: 10.1200/JCO.2000.18.10.2095.
- Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.
- Socinski MA, Schell MJ, Peterman A, Bakri K, Yates S, Gitten R, Unger P, Lee J, Lee JH, Tynan M, Moore M, Kies MS. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer. J Clin Oncol. 2002 Mar 1;20(5):1335-43. doi: 10.1200/JCO.2002.20.5.1335.
- Buter J, Giaccone G. EGFR inhibitors in lung cancer. Oncology (Williston Park). 2005 Nov;19(13):1707-11; discussion 1711-2, 1720-3.
- Eberhard DA, Johnson BE, Amler LC, Goddard AD, Heldens SL, Herbst RS, Ince WL, Janne PA, Januario T, Johnson DH, Klein P, Miller VA, Ostland MA, Ramies DA, Sebisanovic D, Stinson JA, Zhang YR, Seshagiri S, Hillan KJ. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol. 2005 Sep 1;23(25):5900-9. doi: 10.1200/JCO.2005.02.857. Epub 2005 Jul 25.
- Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.
- Fossella FV, Lee JS, Shin DM, Calayag M, Huber M, Perez-Soler R, Murphy WK, Lippman S, Benner S, Glisson B, et al. Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. J Clin Oncol. 1995 Mar;13(3):645-51. doi: 10.1200/JCO.1995.13.3.645.
- MA Jinlan, FENG Fengyi, ZHOU Liqiang, SUN Yan.Pharmacokinetics Study and Clinical Evaluation on Boanmycin.China Pharmacy 16(17):1314-1315, 2005.
- Wang Ping hui, Liu Liping, Hou Yuanshu et al.Phase II Clinical Trial of The New Anticancer Drug-Boanmycin.Chinese Journal of Clinical Oncology 25(9):657-659, 1998.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2012
Finalización primaria (Anticipado)
1 de noviembre de 2016
Finalización del estudio (Anticipado)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2012
Publicado por primera vez (Estimar)
8 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
22 de diciembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
21 de diciembre de 2015
Última verificación
1 de agosto de 2012
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
Otros números de identificación del estudio
- CIH-CHP-201205001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .