Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004238
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-01-28
Brief Title:
10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of 10-Propargyl-10-Deazaaminopterin PDX in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine objective response rate duration of response and time to disease progression in patients with stage IIIB pleural or pericardial disease or stage IV non-small cell lung cancer treated with 10-propargyl-10-deazaaminopterin as first line or second line chemotherapy II Determine the toxicity of this drug in this patient population III Determine duration of survival in these patients IV Determine quality of life of these patients
OUTLINE Patients receive 10-propargyl-10-deazaaminopterin IV on days 1 and 15 Treatment repeats every 4 weeks in the absence of unacceptable toxicity or disease progression Quality of life is assessed at the beginning of each course Patients are followed every 8 weeks for disease progression
PROJECTED ACCRUAL A total of 19-39 patients will be accrued for this study within 12 months
OUTLINE Patients receive 10-propargyl-10-deazaaminopterin IV on days 1 and 15 Treatment repeats every 4 weeks in the absence of unacceptable toxicity or disease progression Quality of life is assessed at the beginning of each course Patients are followed every 8 weeks for disease progression
PROJECTED ACCRUAL A total of 19-39 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| NCI-H99-0045 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067482 | REGISTRY | None | None |