Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00672243
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib + sirolimus — DRUG
    Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.

Study Details

Primary objective: To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus. Secondary objectives: To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and to evaluate progression free survival, radiographic response and overall survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

Key Dates

First listed
May 6, 2008
Start date
Apr 30, 2007
Status verified
Jul 2013
Primary completion
Sep 30, 2008
Completion
Dec 31, 2009

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib + Sirolimus
    Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3 (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.

Primary Outcome Measure

6-month Progression-free Survival (PFS) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Duke University Health System· Durham, NC

Related Studies