Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086879
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2004-07-08
Brief Title:
Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase II of TARCEVA Erlotinib Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-26034-16031 | None | None | None |