- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00022646
Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine.
- Compare the duration of response, time to progressive disease, time to treatment failure, and survival time in patients treated with these regimens.
- Compare the quantitative and qualitative toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to stage of disease (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to one of three treatment arms.
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
- Arm III: Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive up to 6 additional courses of therapy.
Patients are followed every 2 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study within 20 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Estados Unidos, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Estados Unidos, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Health Plaza
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Health System
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Estados Unidos, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, Estados Unidos, 43623-3456
- CCOP - Toledo Community Hospital
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15212-4772
- Allegheny General Hospital
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Estados Unidos, 57104
- CCOP - Sioux Community Cancer Consortium
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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 locally advanced or metastatic non-small cell lung cancer
- Stage IIIB disease that is ineligible for combined modality therapy OR
- Stage IV disease
- Measurable disease
- No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures
- No brain metastases (even if treated)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine clearance at least 45 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to take folic acid or cyanocobalamin (vitamin B12) supplementation
- No uncontrolled infection
- No concurrent chronic debilitating disease
- No weight loss of 10% or more within the past 6 weeks
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic or genetic therapy for lung cancer
- No concurrent immunomodulating agents
Chemotherapy:
- No prior chemotherapy for lung cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy to a different site and recovered
- No prior radiotherapy to 25% or more of bone marrow
- No prior radiotherapy to whole pelvis
- No prior radiotherapy for primary disease
- No concurrent radiotherapy
Surgery:
- More than 4 weeks since prior major surgery
Other:
- No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone)
- No other concurrent cytostatic or cytotoxic therapy
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 |
---|---|
Experimental: Arm I: pemetrexed + gemcitabine
Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
|
|
Experimental: Arm II: pemetrexed + gemcitabine
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
|
|
Experimental: Arm III: pemetrexed + gemcitabine
Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
tumor response rate
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
duration of response
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
time to treatment failure
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
survival
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
time to disease progression
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.
- An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.
- Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.
- Adjei AA, Salavaggione OE, Mandrekar SJ, Dy GK, Ziegler KL, Endo C, Molina JR, Schild SE, Adjei AA. Correlation between polymorphisms of the reduced folate carrier gene (SLC19A1) and survival after pemetrexed-based therapy in non-small cell lung cancer: a North Central Cancer Treatment Group-based exploratory study. J Thorac Oncol. 2010 Sep;5(9):1346-53. doi: 10.1097/JTO.0b013e3181ec18c4.
- Ma CX, Nair S, Thomas S, Mandrekar SJ, Nikcevich DA, Rowland KM, Fitch TR, Windschitl HE, Hillman SL, Schild SE, Jett JR, Obasaju C, Adjei AA; North Central Cancer Treatment Group; Mayo Clinic; Eli Lilly & Company. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5929-37. doi: 10.1200/JCO.2005.13.953.
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
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Antagonistas del ácido fólico
- Gemcitabina
- Pemetrexed
Otros números de identificación del estudio
- NCCTG-N0026
- NCI-2012-02399 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000068838 (Identificador de registro: PDQ (Physician Data Query))
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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