Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052949
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2003-01-24
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate time to progression and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate
II Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug
III Correlate individual patient variation in clinical toxicity andor activity pharmacologic pharmacokineticpharmacodynamic parameters andor biologic correlative laboratory study results responses to this drug with genetic differences in proteins involved in drug response transport metabolism andor mechanism of action
OUTLINE This is a multicenter study Patients are stratified according to length of prior therapy less than 3 months vs at least 3 months
Patients receive oral imatinib mesylate twice daily for 28 days Courses continue in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration
NOTE Patients who develop CNS metastasis as the only site of disease progression receive therapeutic whole-brain radiotherapy and then resume study therapy
PROJECTED ACCRUAL A total of 41 patients for stratum I will be accrued within 21 months and 50 patients for stratum II will be accrued within 25 months for this study
I Determine the response rate time to progression and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate
II Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug
III Correlate individual patient variation in clinical toxicity andor activity pharmacologic pharmacokineticpharmacodynamic parameters andor biologic correlative laboratory study results responses to this drug with genetic differences in proteins involved in drug response transport metabolism andor mechanism of action
OUTLINE This is a multicenter study Patients are stratified according to length of prior therapy less than 3 months vs at least 3 months
Patients receive oral imatinib mesylate twice daily for 28 days Courses continue in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration
NOTE Patients who develop CNS metastasis as the only site of disease progression receive therapeutic whole-brain radiotherapy and then resume study therapy
PROJECTED ACCRUAL A total of 41 patients for stratum I will be accrued within 21 months and 50 patients for stratum II will be accrued within 25 months 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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01801 | REGISTRY | None | None |
| CDR0000269156 | None | None | None |
| NCCTG-N0124 | None | None | None |
| CALGB-30201 | None | None | None |
| N0124 | OTHER | None | None |
| N0124 | OTHER | None | None |