A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT00265317
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • erlotinib — DRUG
    erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
  • sunitinib — DRUG
    Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
  • erlotinib — DRUG
    erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
  • placebo — DRUG
    Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

Study Details

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen

Key Dates

First listed
Dec 14, 2005
Start date
Jun 30, 2006
Status verified
Jan 2013
Primary completion
Jan 31, 2010
Completion
Jan 31, 2012

Study Design

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

Arms

  • Experimental: A
  • Active Comparator: B

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) ]

Locations (18)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteBirminghamAlabama35233-
Pfizer Investigational SiteBirminghamAlabama35294-
Pfizer Investigational SiteMobileAlabama36604-
Pfizer Investigational SiteAntiochCalifornia94531-
Pfizer Investigational SitePalm SpringsCalifornia92262-4885-
Pfizer Investigational SitePleasant HillCalifornia94523-
Pfizer Investigational SiteSan LeandroCalifornia94578-
Pfizer Investigational SiteChicagoIllinois60612-
Pfizer Investigational SiteCity of Saint PetersMissouri63376-
Pfizer Investigational SiteCreve CoeurMissouri63141-
Pfizer Investigational SiteSt LouisMissouri63110-1094-
Pfizer Investigational SiteSt LouisMissouri63110-
Pfizer Investigational SiteChapel HillNorth Carolina27599-7600-
Pfizer Investigational SiteClintonNorth Carolina28328-
Pfizer Investigational SiteGoldsboroNorth Carolina27534-
Pfizer Investigational SiteWilsonNorth Carolina27893-
Pfizer Investigational SiteClevelandOhio44106-
Pfizer Investigational SiteHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
Pfizer Investigational Site· Birmingham, ALPfizer Investigational Site· Mobile, ALPfizer Investigational Site· Antioch, CAPfizer Investigational Site· Palm Springs, CAPfizer Investigational Site· Pleasant Hill, CAPfizer Investigational Site· San Leandro, CA

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