Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033722
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2002-04-09
Brief Title:
Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Tularik
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multicenter Study Of Lometrexol Sodium And Folic Acid In Subjects With Previously Treated Stage IIIB or IV Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2002-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Folic acid may be effective in preventing or lessening the side effects of lometrexol Combining lometrexol with folic acid may be an effective treatment for non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining lometrexol with folic acid in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been previously treated
PURPOSE Phase II trial to study the effectiveness of combining lometrexol with folic acid in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been previously treated
Detailed Description:
OBJECTIVES
Determine the overall response rate in patients with previously treated stage IIIB or IV non-small cell lung cancer when treated with lometrexol and folic acid
Determine the complete response rate duration of response and time to progression in patients treated with this regimen
Determine the 1-year survival rate and overall survival in patients treated with this regimen
Determine the safety profile of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral folic acid once daily on days -7 to 6 Patients also receive lometrexol IV over 30-60 seconds on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed up to 2 months after removal from study and then every 3 months thereafter
PROJECTED ACCRUAL A total of 50-100 patients will be accrued for this study
Determine the overall response rate in patients with previously treated stage IIIB or IV non-small cell lung cancer when treated with lometrexol and folic acid
Determine the complete response rate duration of response and time to progression in patients treated with this regimen
Determine the 1-year survival rate and overall survival in patients treated with this regimen
Determine the safety profile of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral folic acid once daily on days -7 to 6 Patients also receive lometrexol IV over 30-60 seconds on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed up to 2 months after removal from study and then every 3 months thereafter
PROJECTED ACCRUAL A total of 50-100 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 |
|---|---|---|---|
| USO-01103 | None | None | None |
| TULA-T064031 | None | None | None |