- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00062322
Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer
Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan and cisplatin may also make the tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: This phase I trial is studying the side effects of neoadjuvant radiation therapy given together with irinotecan and cisplatin followed by surgery in treating patients with limited-stage small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
- Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer.
- Determine the pathologic complete response rate of patients treated with this regimen.
- Correlate the level of vascular endothelial growth factor with treatment response and disease outcome in patients treated with this regimen.
- Correlate genetic polymorphisms in cytochrome P450 1A1, glutathione S-transferase M1 and P1, myeloperoxidase, and NAD(p)H: quinone oxidoreductase with treatment response and disease outcome in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Induction chemotherapy: Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 90 minutes on days 1 and 8.
- Chemoradiotherapy: Beginning on day 21, patients receive chemoradiotherapy comprising radiotherapy once daily, 5 days a week for 4 weeks and then twice daily for 4 days. Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly concurrently with radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
At the completion of chemoradiotherapy, patients are evaluated for surgery. Patients who are candidates for surgery receive one additional course of cisplatin IV and irinotecan IV. Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and cisplatin IV and irinotecan IV as in chemoradiotherapy.
- Surgery: Approximately 2-4 weeks after the last dose of chemotherapy, patients undergo surgery.
Patients are followed every 4 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
- Fox Chase Cancer Center
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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 small cell lung cancer
Limited stage disease (clinical stage I-IIIA) and meets the following criteria:
- Confined to 1 hemithorax
- No T4 disease based on malignant pleural effusion
- No N3 disease based on contralateral hilar or supraclavicular involvement
- Contralateral mediastinal (N3) nodes greater than 1.5 cm on CT scan must be biopsied to rule out pathologic involvement
- Measurable or evaluable disease
- Tumor must be able to be encompassed by limited radiotherapy field without significantly compromising pulmonary function
- No pleural effusion visible on chest x-ray (regardless of cytology)
- No prior complete tumor resection
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- No known Gilbert's disease
Renal
- Creatinine no greater than 1.5 mg/dL
- Calcium less than 12.0 mg/dL
Cardiovascular
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No uncontrolled arrhythmias
- No active unstable angina
Pulmonary
- Calculated postoperative FEV_1 at least 800 cc
- No chronic obstructive pulmonary disease with FEV_1 no greater than 1 L or uncontrolled bronchospasm in the unaffected lung
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other noninvasive malignancy
- No history of seizures
- No history of uncontrolled psychiatric illness that would preclude giving informed consent or complying with study
- No active or uncontrolled infection
- No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL)
- No other concurrent serious medical illness
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior irinotecan
- No prior topotecan
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest or other areas containing 30% or more of marrow-bearing bone
Surgery
- See Disease Characteristics
Other
- No concurrent phenytoin, phenobarbital, or other antiepileptic prophylactic drugs
- No concurrent amifostine
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Steven Feigenberg, MD, Fox Chase Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa
- Inhibidores de la topoisomerasa I
- Irinotecán
Otros números de identificación del estudio
- CDR0000304720
- P30CA006927 (Subvención/contrato del NIH de EE. UU.)
- FCCC-02613
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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