- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00041015
Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
- Compare the response rates, response duration, and time to progression in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the patient-perceived disease status and well being in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
- Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.
Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung carcinoma (SCLC)
- No prior chemotherapy for SCLC OR
- No chemotherapy within 5 years of diagnosis of SCLC
- Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing
No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI
- Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 9.0 g/dL
- WBC at least 3,500/mm3
- Platelet count at least 100,000/mm3
- Neutrophil count at least 1,500/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No pre-existing renal impairment that would preclude cisplatin use
Gastrointestinal:
No clinical evidence of any gastrointestinal (GI) conditions including:
- Removal of a portion of the stomach
- History of recent obstruction of the GI tract
- GI autonomic neuropathy
- Ulcerative colitis
- Crohn's disease
- Malabsorption syndrome
- Treatment with cyclosporine that would alter absorption or GI motility
- No other conditions that would preclude absorption of oral topotecan
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study
- No active infection
- No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer
- No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance
- No prior allergic reactions to compounds chemically related to study drugs
- No pre-existing hearing impairment that would preclude cisplatin use
- No overall medical condition for which study drugs would be inappropriate
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy for SCLC
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy for SCLC
Endocrine therapy:
- See Disease Characteristics
- No concurrent hormonal therapy for SCLC
Radiotherapy:
- See Disease Characteristics
- At least 24 hours since prior radiotherapy with no expected bone marrow suppression
- Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium)
- No concurrent radiotherapy for SCLC
- No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator
Surgery:
- At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient)
Other:
- More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs
- No other concurrent investigational therapy for SCLC
- No concurrent cyclosporine
- No concurrent drugs that would preclude absorption of oral topotecan
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
|
|
Experimental: Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Nathan Levitan, MD, Case Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Inhibidores de la topoisomerasa I
- Etopósido
- Cisplatino
- Topotecán
Otros números de identificación del estudio
- SKF1501
- CWRU-070144
- SB-389
- SB-SKF-104864A
- SB-SKF-1501
- NCI-G02-2092
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. .
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