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)

PHASE2TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 8, 2005

Primary Completion Date

January 16, 2008

Study Completion Date

January 16, 2008

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Temozolomide and radiotherapy

Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).

PROCEDURE

Whole brain radiotherapy

2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AESCA Pharma GmbH

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00266812 - 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) | Biotech Hunter | Biotech Hunter