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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Metastases, Neoplasm

Brain Neoplasms

Treatments

Drug: temozolomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00034697

P02143

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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