Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Lung cancer is the second most common cancer diagnosed for both genders in the United States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004. Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced disease is limited. The study will test two chemotherapy agents, carboplatin and paclitaxel, in combination with a newly approved drug called cetuximab, which is continuing to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR.
Rationale:
The present study is built upon the data from previous studies, incorporating cetuximab into each of two regimens of paclitaxel plus carboplatin. The results of prior studies using paclitaxel and carboplatin demonstrate that these drugs in combination, using a variety of schedules, are both safe and effective as therapy for advanced or metastatic NSCLC. The addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIB/IV NSCLC.
Research Hypothesis:
Subjects with previously-untreated stage IIIB/IV NSCLC who receive a combination of paclitaxel, carboplatin, and cetuximab will have a progression-free survival rate greater than that previously reported for subjects receiving the combination of paclitaxel and carboplatin.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90089
- ImClone Investigational Site
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Santa Monica, California, Estados Unidos, 90404
- ImClone Investigational Site
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- ImClone Investigational Site
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Florida
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Orlando, Florida, Estados Unidos, 32804
- ImClone Investigational Site
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St. Petersburg, Florida, Estados Unidos, 33705
- ImClone Investigational Site
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Georgia
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Tucker, Georgia, Estados Unidos, 30084
- ImClone Investigational Site
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Indiana
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Terra Haute, Indiana, Estados Unidos, 47804
- ImClone Investigational Site
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- ImClone Investigational Site
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Maryland
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Baltimore, Maryland, Estados Unidos, 21204
- ImClone Investigational Site
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Michigan
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Ypsilanti, Michigan, Estados Unidos, 48197
- ImClone Investigational Site
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New Jersey
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Newark, New Jersey, Estados Unidos, 07112
- ImClone Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- ImClone Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19141
- ImClone Investigational Site
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29209
- ImClone Investigational Site
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37920
- ImClone Investigational Site
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Texas
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Houston, Texas, Estados Unidos, 77024
- ImClone Investigational Site
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Temple, Texas, Estados Unidos, 76508
- ImClone Investigational Site
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Virginia
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Richmond, Virginia, Estados Unidos, 23230
- ImClone Investigational Site
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- ImClone Investigational Site
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26506
- ImClone Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
To be eligible for the study, subjects must fulfill all of the following criteria and have a complete signed informed consent form.
- Subjects must have signed an approved informed consent.
- Subjects with histologically or cytologically documented stage IIIB (supraclavicular lymph node, high neck node, or pleural effusion involvement) or IV NSCLC. Disease must be newly diagnosed or recurrent at least 1 year post adjuvant therapy.
- Subjects with measurable disease.
- Subjects with ECOG performance status 0-1.
- Subjects with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment and be off steroids.
- Radiotherapy must have been completed > 2 weeks prior to enrollment and the subject must have recovered from all adverse effects of prior radiotherapy. No previous irradiation to the only area of measurable disease. New lesions that developed in a previously irradiated area will be allowed.
- If diagnostic tissue or slides are available for a subject, these must be submitted for testing of EGFR status.
- Subjects ≥18 years of age.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35mIU/mL]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
Subjects with adequate hematologic function defined as: ANC ≥1,500/mm 3 ; WBC
≥3,000/mm 3 ; platelets ≥100,000/mm 3 ; and hemoglobin ≥9 g/dL.
- Subjects with adequate hepatic function defined as: total bilirubin ≤1.5 x upper limit of normal (ULN) or AST ≤2.5 x ULN.
- Subjects with adequate renal function defined as a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute.
Exclusion Criteria:
Any of the following criteria will make the subject ineligible to participate in this study.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Subjects who have had prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
- Subjects with significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction, myocardial infarction within the past year, or cardiac ventricular arrythmias requiring medication.
- Subjects with an uncontrolled seizure disorder, or active neurological disease.
- Subjects with symptomatic brain metastasis. Prohibited Therapies and/or Medications
- Subjects who have received prior systemic chemotherapy. Subjects with no more than one prior adjuvant regimen for initially diagnosed disease are eligible for the study.
- Subjects with a history of prior cetuximab or other therapy that specifically and directly targets the EGFR pathway.
- Subject with prior severe infusion reaction to a monoclonal antibody.
- Subjects with know allergy to Cremophor EL.
- Subjects with known peripheral neuropathy (> grade 1).
- Subjects with prior erythropoietin (i.e., Epogen, Procrit) treatment.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
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 |
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Comparador activo: Arm A (3-week cycle)
Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks. |
(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B.
Otros nombres:
(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.
Otros nombres:
225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks.
OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.
Otros nombres:
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Comparador activo: Arm B (4-week cycle)
Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. Paclitaxel 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle. Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks. |
(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B.
Otros nombres:
(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.
Otros nombres:
225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks.
OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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To estimate median progression free survival and the progression free survival rate
Periodo de tiempo: 6 months
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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To estimate the overall response rate in each treatment arm
Periodo de tiempo: 6 months
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6 months
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To estimate median survival and the survival rate at one year in each treatment arm
Periodo de tiempo: 6 months
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6 months
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To evaluate the toxicity profile of each treatment arm
Periodo de tiempo: 6 months
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6 months
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To explore the relationship between EGFR expression and the "clinical benefit" received from each treatment regimen
Periodo de tiempo: 6 months
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6 months
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To evaluate symptom response rate in each treatment arm using the Lung Cancer Subscale (LCS) of the FACT-L
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antineoplásicos inmunológicos
- Carboplatino
- Paclitaxel
- Cetuximab
Otros números de identificación del estudio
- CA225-058
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