Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039494
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2002-06-06
Brief Title:
Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This pilot phase II trial is studying the side effects and best dose of erlotinib when given with temozolomide and radiation therapy and to see how well they work in treating patients with glioblastoma multiforme or other brain tumors Radiation therapy uses high-energy x-rays to damage tumor cells Erlotinib may interfere with the growth of tumor cells slow the growth of the tumor and make the tumor cells more sensitive to radiation therapy Drugs used in chemotherapy such as temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib and temozolomide with radiation therapy may kill more tumor cells
Detailed Description:
PILOT STUDY OBJECTIVES
I Determine the maximum tolerated dose of erlotinib administered with temozolomide and radiotherapy in patients with glioblastoma multiforme or other grade 4 brain tumors who are currently on enzyme-inducing anticonvulsant EIAC therapy vs no EIAC therapy
II Determine the safety and tolerability of this regimen in these patients III Determine the toxic effects of this regimen in these patients IV Determine the efficacy of this regimen in terms of 1-year survival in these patients
PHASE II OBJECTIVES
I Determine the response rate and time to progression in patients treated with this regimen
II Determine the 6-month progression-free survival of patients treated with this regimen
III Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter dose-escalation pilot study of erlotinib followed by a phase II study Patients are stratified according to concurrent enzyme-inducing anticonvulsant drug use yes vs no
PILOT STUDY Patients receive oral erlotinib once daily After 1 week of erlotinib alone patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks After completion of radiotherapy patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity Beginning 4 weeks after the completion of radiotherapy patients also receive oral temozolomide once daily for 5 days Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PHASE II Once the MTD of erlotinib is determined additional patients are treated with erlotinib at the MTD temozolomide and radiotherapy as above
Patients are followed every 3 months for 5 years and then annually for 10 years
I Determine the maximum tolerated dose of erlotinib administered with temozolomide and radiotherapy in patients with glioblastoma multiforme or other grade 4 brain tumors who are currently on enzyme-inducing anticonvulsant EIAC therapy vs no EIAC therapy
II Determine the safety and tolerability of this regimen in these patients III Determine the toxic effects of this regimen in these patients IV Determine the efficacy of this regimen in terms of 1-year survival in these patients
PHASE II OBJECTIVES
I Determine the response rate and time to progression in patients treated with this regimen
II Determine the 6-month progression-free survival of patients treated with this regimen
III Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter dose-escalation pilot study of erlotinib followed by a phase II study Patients are stratified according to concurrent enzyme-inducing anticonvulsant drug use yes vs no
PILOT STUDY Patients receive oral erlotinib once daily After 1 week of erlotinib alone patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks After completion of radiotherapy patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity Beginning 4 weeks after the completion of radiotherapy patients also receive oral temozolomide once daily for 5 days Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PHASE II Once the MTD of erlotinib is determined additional patients are treated with erlotinib at the MTD temozolomide and radiotherapy as above
Patients are followed every 3 months for 5 years and then annually for 10 years
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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N0177 | None | None | None |
| CDR0000069388 | None | None | None |
| NCCTG-N0177 | None | None | None |