Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Brain Neoplasms

Treatments

Drug: Temozolomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00076856

P03247

Details and patient eligibility

About

The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Age greater than or equal to 18
Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
At least one brain metastasis diagnosed within 30 days of randomization
Brain metastases must not have been previously treated with WBRT or radiosurgery
No more than 2 sites of extracranial metastases
May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
Meets protocol requirements for specified laboratory values.
Written informed consent and cooperation of patient
Appropriate use of effective contraception if of childbearing potential.
Karnofsky Performance Status KPS greater than 70
Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)