Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

Phase 2TerminatedNCT00034697

Merck Sharp & Dohme LLC24 enrolled

Overview

Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metastases, Neoplasm Carcinoma, Non-Small-Cell Lung Brain Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic confirmation of non-small-cell lung cancer * Stable systemic disease * Maximum of one prior chemotherapy regimen for metastatic systemic disease * Radiotherapy for local control or palliative bony lesions is allowed * Karnofsky of greater than or equal to 70% * Adequate hematologic, renal and liver function Exclusion Criteria: * Patients eligible for surgery of the brain * Any previous chemotherapy for the brain metastasis * Chemotherapy within 4 weeks or previous temozolomide * Prior radiotherapy to the brain * Radiation therapy to greater than 50% of the bone marrow * Insufficient recovery from previous therapies * Active nonmalignant systemic disease * Inability to take oral medication * Pregnant or nursing women * Non use of adequate contraceptive techniques, negative urine pregnancy test is required * Known AIDS related illness