Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme
- Compare the therapeutic activity of erlotinib vs temozolomide or carmustine in patients
with recurrent glioblastoma multiforme.
- Compare 6-month progression-free survival in patients treated with these drugs.
- Compare the safety of these drugs in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib* once daily on day 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients treated with enzyme inducing anti-epileptic drugs (EIAEDs) receive a higher
dose of erlotinib than patients not receiving any anti-epileptic drugs or EIAEDs.
- Arm II: Patients who have not received prior temozolomide are assigned to receive
temozolomide. Patients who have received prior temozolomide are assigned to receive
carmustine. Patients receive 1 of the following treatment regimens:
- Patients receive oral temozolomide* once daily on days 1-5. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
- Patients receive carmustine IV once daily on days 1-3. Treatment repeats every 56
days for up to 5 courses in the absence of disease progression or unacceptable
NOTE: *Chemotherapy-naïve patients receive a higher dose of temozolomide than patients who
have received prior adjuvant chemotherapy.
Patients are followed every 8 weeks until disease progression and then every 3 months
PROJECTED ACCRUAL: A total of 100-110 patients (50-55 per treatment arm) will be accrued for
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
Martin J. van Den Bent, MD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government