Phase I/II dose escalation trial of concurrent temozolomide and whole brain radiation therapy for multiple brain metastasis.

This study sought to establish the recommended phase II dose and efficacy of temozolomide (TMZ) with concurrent radiotherapy in patients with brain metastases. Patients were stratified by prior systemic therapy (≤1 vs. ≥2) and enrolled in cohorts of escalating doses of daily TMZ for 14 days (group A: 75, 95, 115, 135, or 150 mg/m(2), group B: 75, 90, 105, 120, or 135 mg/m(2)).