Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for
      their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in
      different ways to stop tumor cells from dividing so they stop growing or die. It is not yet
      known whether erlotinib is more effective than temozolomide or carmustine in treating
      recurrent glioblastoma multiforme.

      PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works
      compared to temozolomide or carmustine in treating patients with recurrent glioblastoma
      multiforme.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  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.

      Secondary

        -  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
                toxicity.

      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
      thereafter.

      PROJECTED ACCRUAL: A total of 100-110 patients (50-55 per treatment arm) will be accrued for
      this study.
    

Intervention name(s): carmustine; erlotinib hydrochloride; temozolomide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Temozolomide; Carmustine; Erlotinib Hydrochloride
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma