Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Temozolomide and radiotherapy

Procedure: Whole brain radiotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00266812

P04071

Details and patient eligibility

About

This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Prior histologic confirmation of non-small cell lung cancer (NSCLC).
Optional: NSCLC histologic confirmation of metastasis of NSCLC.
Presence of unidimensionally measurable disease in the brain.
No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
Age: >18 years.
Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy
Karnofsky Performance status >=70%.
Absolute neutrophil count (ANC) >1,500/mm^3, platelets >100,000/mm^3, hemoglobin >8 g/dL.
Serum creatinine and bilirubin <1.5 times upper normal limit of testing laboratory.
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <3 times upper limit of testing laboratory.
Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
Prior neurosurgery >2 weeks from initiating treatment with temozolomide.
Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide.
Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception.
Written informed consent.

Exclusion criteria

Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
Surgery within two weeks prior to temozolomide administration.
Recursive Partitioning Analysis (RPA) class III
Patients with a single brain metastasis amenable to radiosurgery of resection
Known Human Immunodeficiency Virus (HIV) disease.
Acute infection requiring intravenous antibiotics.
Any reason making compliance to the protocol improbable.