Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT00283244
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.

Key Dates

Start date
Mar 31, 2006
Status verified
Mar 2017
Primary completion
Sep 30, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
147 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
  • Experimental: Arm B
    Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
  • Experimental: Arm C
    Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily

Primary Outcome Measure

Progression-free Survival [ Time Frame: Six months ]

Locations (11)

FacilityCityStateZIP
Highlands Oncology Group - FayettevilleFayettevilleArkansas72703
Summit Cancer CareSavannahGeorgia31405
Evanston HospitalEvanstonIllinois60201-1781
Hackensack University Medical Center Cancer CenterHackensackNew Jersey07601
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295
Blumenthal Cancer Center at Carolinas Medical CenterCharlotteNorth Carolina28232-2861
Batte Cancer Center at Northeast Medical CenterConcordNorth Carolina28025
Cape Fear Valley Medical Center Cancer CenterFayettevilleNorth Carolina28302-2000
Rex Cancer Center at Rex HospitalRaleighNorth Carolina27607
Kingsport Hematology-Oncology AssociatesKingsportTennessee37660
University of Tennessee Cancer Institute - MemphisMemphisTennessee38104

Find similar trials in Fayetteville, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group - Fayetteville· Fayetteville, ARSummit Cancer Care· Savannah, GAEvanston Hospital· Evanston, ILHackensack University Medical Center Cancer Center· Hackensack, NJLineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NCBlumenthal Cancer Center at Carolinas Medical Center· Charlotte, NC

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