Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This is a Phase I/II trial of elderly patients (> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed[Alimta™], Bevacizumab and Erlotinib[Tarceva™]) which are given every 28 days.
This is a Phase I/II trial of elderly patients (> 70 years of age) with previously
un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural
effusion) and stage IV disease will be enrolled.
Treatment Regimen:
Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day 1 and Day
15; Bevacizumab 10mg/Kilogram(Kg) I. V. Day 1 and Day 15; Erlotinib (Tarceva™) 150mg Per
Orally(PO) Once Daily(QD) for 7 days starting day 2 and day 15; Repeat cycles every 28 days.
All three drugs will be continued for two cycles after maximal response. After which patient
will be maintained only on the Bevacizumab and Erlotinib until progression. If patient has
stable disease after the first two cycles then patient will be given another two cycles with
all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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