Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00609804
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Sorafenib — DRUG
    Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
  • Erlotinib — DRUG
    Erlotinib 150 mg once daily by mouth

Study Details

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Key Dates

First listed
Feb 7, 2008
Start date
Mar 31, 2008
Status verified
Mar 2016
Primary completion
May 31, 2012
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: Sorafenib+Erlotinib
    Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth
  • Active Comparator: Sorafenib
    Sorafenib 400 mg twice daily by mouth.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 18 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Wellstar Cancer ResearchMariettaGeorgia30060-
Providence Medical GroupTerre HauteIndiana47802-
Norton Cancer InstituteLouisvilleKentucky40207-
Hematology Oncology Clinic, LLPBaton RougeLouisiana70806-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
National Capital Clinical Research ConsortiumBethesdaMaryland20817-
Jackson Oncology AssociatesJacksonMississippi39202-
St. Louis Cancer CareChesterfieldMissouri63017-
Research Medical CenterKansas CityMissouri64132-
Nebraska Methodist Cancer CenterOmahaNebraska68114-
Hematology-Oncology Associates of Northern NJMorristownNew Jersey07960-
Associates in Hematology OncologyChattanoogaTennessee37404-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-

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, GAProvidence Medical Group· Terre Haute, INNorton Cancer Institute· Louisville, KYHematology Oncology Clinic, LLP· Baton Rouge, LA

Related Studies