Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064064
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2003-07-08
Brief Title:
3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2004-08
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:
RATIONALE Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine
Determine the progression-free and overall survival in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 22-50 patients will be accrued for this study
Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine
Determine the progression-free and overall survival in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3 Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 22-50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VION-CLI-030 | None | None | None |
| MDA-ID-030143 | None | None | None |