A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

CompletadoFase 2ClinicalTrials.gov

ID: NCT00723957Tipo: INTERVENTIONALInicio: 1 de dic de 2008Fin estimado: 1 de ago de 2011

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
Karnofsky performance status of 70-100
Life expectancy of at least 3 months
Men and women, ages 18 years and older

Criterios de exclusión

Uncontrolled brain metastases
Peripheral neuropathy greater than Grade 1
Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
Known HIV-positive status
Absolute neutrophil count lower than 1500 cells mm\^3
Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
Aspartate transaminase or alanine transaminase level higher than 2.5\*ULN
Serum creatine level of 1.5 mg/dL or higher
Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
Any prior antineoplastic systemic regimens.

Intervenciones

drug

Ixabepilone, 32 mg/m^2

Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2

drug

Paclitaxel, 200 mg/m^2

IV solutions, paclitaxel, 200 mg/m\^2

drug

Carboplatin (area under the concentration curve [AUC] 6)

Carboplatin (AUC 6) day 1, every 21 days, 6 cycles

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Patrocinadores

PrincipalR-Pharm

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