QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC

Sponsor
University of Medicine and Dentistry of New Jersey
Study ID
NCT00385398
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.
  • temozolomide — DRUG
    Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.
  • stereotactic radiosurgery — RADIATION
    Stereotactic radiosurgery will be performed prior to chemotherapy.

Study Details

RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment. PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.

Key Dates

First listed
Oct 9, 2006
Start date
Jul 31, 2008
Status verified
Aug 2013
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

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

Primary Outcome Measure

Cognitive function [ Time Frame: 2 years ]

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