Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00445588
Phase
PHASE2
Status
Completed

Conditions

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    150mg Given orally once daily
  • sorafenib tosylate — DRUG
    400mg Given orally twice daily
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may kill more tumor cells.

Key Dates

First listed
Mar 9, 2007
Start date
Jan 31, 2007
Status verified
Mar 2016
Primary completion
Aug 31, 2009
Completion
Aug 31, 2009

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study

Primary Outcome Measure

Overall Survival [ Time Frame: Time of first day of the treatment to death, assessed up to 2 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Johns Hopkins UniversityBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48202-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Cleveland ClinicClevelandOhio44195-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GAJohns Hopkins University· Baltimore, MDMassachusetts General Hospital· Boston, MAHenry Ford Hospital· Detroit, MI

Related Studies