Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385398
Status:
WITHDRAWN
Last Update Posted:
2013-09-02
First Post:
2006-10-05
Brief Title:
QOL-Stereotactic RadioSurgery Temozolomide Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Phase II Quality of Life Study of Stereotactic RadioSurgery Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding and drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Treatment with radiosurgery temozolomide and erlotinib may affect brain function the ability to think learn remember and judge in patients with non-small cell lung cancer and brain metastases A study that evaluates brain function may help doctors plan the best treatment
PURPOSE This phase II trial is studying the effect of radiosurgery temozolomide and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases
PURPOSE This phase II trial is studying the effect of radiosurgery temozolomide and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases
Detailed Description:
OBJECTIVES
Primary
Determine the effect of stereotactic radiosurgery temozolomide and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases
Secondary
Determine the feasibility and safety of this regimen in terms of tumor response time to tumor progression in brain survival physical functioning and quality of life in these patients
Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients
OUTLINE This is a multicenter study
Patients undergo stereotactic radiosurgery on day -7 Patients receive oral temozolomide once daily on days 1-5 and oral erlotinib hydrochloride once daily on days 1-23 Treatment with temozolomide and erlotinib hydrochloride repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo cognitive function evaluation as measured by Mini-Mental Status Exam administration and scoring quality of life assessment as measured by Functional Assessment of Cancer Therapy subscale and physical functioning assessment as measured by Katz index of activities of daily living and Karnofsky performance status at baseline and then every 8 weeks during study treatment
Tumor tissue is examined by O6-methylguanine-DNA methyltransferase MGMT gene promotor methylation
After completion of study therapy patients are followed every 3 months
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
Primary
Determine the effect of stereotactic radiosurgery temozolomide and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases
Secondary
Determine the feasibility and safety of this regimen in terms of tumor response time to tumor progression in brain survival physical functioning and quality of life in these patients
Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients
OUTLINE This is a multicenter study
Patients undergo stereotactic radiosurgery on day -7 Patients receive oral temozolomide once daily on days 1-5 and oral erlotinib hydrochloride once daily on days 1-23 Treatment with temozolomide and erlotinib hydrochloride repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo cognitive function evaluation as measured by Mini-Mental Status Exam administration and scoring quality of life assessment as measured by Functional Assessment of Cancer Therapy subscale and physical functioning assessment as measured by Katz index of activities of daily living and Karnofsky performance status at baseline and then every 8 weeks during study treatment
Tumor tissue is examined by O6-methylguanine-DNA methyltransferase MGMT gene promotor methylation
After completion of study therapy patients are followed every 3 months
PROJECTED ACCRUAL A total of 54 patients 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 |
|---|---|---|---|
| P30CA072720 | NIH | None | None |
| 0220060108 | OTHER | None | None |
| CINJ-NJ1506 | None | None | None |
| CDR0000539474 | Other Identifier | IRB Number | httpsreporternihgovquickSearchP30CA072720 |