A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Pfizer
Study ID
NCT00769067
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Continuous oral dosing at 150 mg daily.
  • PF-00299804 — DRUG
    Continuous oral dosing at 45mg daily

Study Details

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Key Dates

First listed
Oct 8, 2008
Start date
Nov 30, 2008
Status verified
Sep 2015
Primary completion
Oct 31, 2010
Completion
Aug 31, 2014

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
  • Experimental: B

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks ]

Locations (26)

FacilityCityStateZIPSite coordinators
Northwest Alabama Cancer CenterMuscle ShoalsAlabama35661-
Agajanian Institute of Oncology and HematologyMontebelloCalifornia90640-
Bridgeport HospitalBridgeportConnecticut06610-
Wittingham Cancer Center @ Norwalk HospitalNorwalkConnecticut06856-
Medical Oncology & Hematology, P.C.WaterburyConnecticut06708-
Winship Cancer Institute at Emory UniversityAtlantaGeorgia30322-
Winship Cancer Institute at Grady Health SystemsAtlantaGeorgia30303-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-1013-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Augusta Oncology Associates, P.C.AugustaGeorgia30901-
Augusta Oncology Associates, PCAugustaGeorgia30909-
John B. Amos Cancer CenterColumbusGeorgia31904-
Georgia Cancer SpecialistsDecaturGeorgia30033-
The Longstreet Cancer CenterGainesvilleGeorgia30501-
Central Georgia Cancer Care, P.C.MaconGeorgia31201-
Northwest Georgia Oncology CenterMariettaGeorgia30106-
Central Georgia Cancer Care, P.C.Warner RobinsGeorgia31088-2259-
Kootenai Cancer CenterPost FallsIdaho83854-
Kootenai Cancer Center at Post FallsPost FallsIdaho83854-
Midwestern Regional Medical CenterZionIllinois60099-
Center for Blood and Cancer DisordersBethesdaMaryland20817-
Associates in Oncology/Hematology, PCRockvilleMaryland20850-
University of Minnesota Cancer CenterMinneapolisMinnesota55455-
The West ClinicMemphisTennessee38120-
Oncology/Hematology AssociatesClarksburgWest Virginia26301-

Find similar trials in Muscle Shoals, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Northwest Alabama Cancer Center· Muscle Shoals, ALAgajanian Institute of Oncology and Hematology· Montebello, CABridgeport Hospital· Bridgeport, CTWittingham Cancer Center @ Norwalk Hospital· Norwalk, CTMedical Oncology & Hematology, P.C.· Waterbury, CTWinship Cancer Institute at Emory University· Atlanta, GA

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