A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT00087711Tipo: INTERVENTIONALInicio: 1 de jul de 2004Fin estimado: 1 de mar de 2008

Traducción no disponible, mostrando original

Resumen

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
No prior chemotherapy for lung cancer.
Patients must have at least one uni-dimensionally measurable lesion.
Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Criterios de exclusión

Treatment with any drug within the last 30 days that has not received regulatory approval.
Serious cardiac condition.
Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
Presence of fluid retention that cannot be controlled by drainage.

Intervenciones

drug

pemetrexed

500 mg/m2, IV q 21 days x 6 cycles

drug

gemcitabine

1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles

drug

cisplatin

75 mg/m2, IV, q 21 days x 6 cycles

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Bahía Blanca, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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