WBRT & Erlotinib in Advanced NSCLC and Brain Metastases

Sponsor
University College, London
Study ID
NCT00554775
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
  • placebo — DRUG
    WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride

Study Details

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases. PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.

Key Dates

First listed
Nov 7, 2007
Start date
Jan 31, 2008
Status verified
Dec 2011
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

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

Arms

  • Experimental: erlotinib hydrochloride
    WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
  • Placebo Comparator: placebo
    WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm

Primary Outcome Measure

Neurological progression-free survival at 2 months [ Time Frame: at 2 months ]

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