Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC

Part of paid clinical trials in Waterbury, Connecticut.

Sponsor
Accelerated Community Oncology Research Network
Study ID
NCT00517595
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed and Gemcitabine plus Bevacizumab — DRUG
    Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m\^2 and gemcitabine 1500 mg/m\^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.

Study Details

The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden.

Key Dates

First listed
Aug 17, 2007
Start date
Aug 31, 2007
Status verified
Mar 2012
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Medical Oncology & HematologyWaterburyConnecticut06708-
Augusta Oncology AssociatesAugustaGeorgia30901-
Central Georgia Cancer CareMaconGeorgia31201-
Northwest Georgia Oncology CenterMariettaGeorgia30060-
Hematology Oncology Centers of the Northern RockiesBillingsMontana59101-
Tri-County Oncology Hematology AssociatesCantonOhio44718-
Pacific Oncology, PCPortlandOregon97225-
Pennsylvania Oncology Hematology AssociatesPhiladelphiaPennsylvania19106-
The West ClinicMemphisTennessee38120-
Cancer Specialists of TidewaterChesapeakeVirginia23320-

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