Conditions: Non-Small Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Single Arm Phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer

Interventions: intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Pemetrexed
Intervention descriptions: intervention 1: Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. intervention 2: Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. intervention 3: Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.

Protocol document: