NCT00351039

Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days.
DRUG	Erlotinib	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.
DRUG	Pemetrexed	Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-07-12
• Last updated: 2017-03-23
• Results posted: 2010-08-30

Locations

1 site across 1 country: United States