Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00600015
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib + Sorafenib — DRUG
    Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day.
  • Erlotinib + Placebo — DRUG
    Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.

Study Details

This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.

Key Dates

First listed
Jan 24, 2008
Start date
Feb 29, 2008
Status verified
Feb 2022
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009

Study Design

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

Arms

  • Experimental: Combination Therapy
    Erlotinib + Sorafenib
  • Placebo Comparator: Placebo
    Erlotinib + Placebo

Primary Outcome Measure

Overall Objective Response Rate (ORR) [ Time Frame: 18 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Wellstar Cancer ResearchMariettaGeorgia30060-
Kansas City Cancer CentersOverland ParkKansas66210-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Grand Rapids Clinical Oncology ProgramGrand RapidsMichigan49503-
Methodist Cancer CenterOmahaNebraska68114-
Cancer Care of Western North CarolinaAshevilleNorth Carolina28801-
Oncology Hematology CareCincinnatiOhio45242-
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister CenterColumbusOhio43219-
South Carolina Oncology Associates, PAColumbiaSouth Carolina29210-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Family Cancer CenterColliervilleTennessee38017-
Tennessee Oncology, PLLCNashvilleTennessee37023-
Coastal Bend Cancer CenterCorpus ChristiTexas78463-
Virginia Cancer InstituteRichmondVirginia23235-

Find similar trials in Fort Myers, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Florida Cancer Specialists· Fort Myers, FLNortheast Georgia Medical Center· Gainesville, GAWellstar Cancer Research· Marietta, GAKansas City Cancer Centers· Overland Park, KSCenter for Cancer and Blood Disorders· Bethesda, MDGrand Rapids Clinical Oncology Program· Grand Rapids, MI

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