Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077415
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2004-02-10
Brief Title:
3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer
Sponsor:
Cancer Therapeutics Research Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study Of Triapine Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as 3-AP and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with stage III or IV recurrent non-small cell lung cancer treated with 3-AP Triapine and gemcitabine as second-line therapy
Secondary
Determine the response duration median time to progression and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the effect of 3-AP Triapine on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen
OUTLINE This is an open-label multicenter study Patients are stratified according to participating center
Patients receive 3-AP Triapine IV over 4 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE For course 1 only gemcitabine is administered alone on day 1 and in combination with 3-AP Triapine on days 8 and 15
Patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 15-31 patients will be accrued for this study within 75-21 months
Primary
Determine the objective response rate in patients with stage III or IV recurrent non-small cell lung cancer treated with 3-AP Triapine and gemcitabine as second-line therapy
Secondary
Determine the response duration median time to progression and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the effect of 3-AP Triapine on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen
OUTLINE This is an open-label multicenter study Patients are stratified according to participating center
Patients receive 3-AP Triapine IV over 4 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE For course 1 only gemcitabine is administered alone on day 1 and in combination with 3-AP Triapine on days 8 and 15
Patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 15-31 patients will be accrued for this study within 75-21 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 |
|---|---|---|---|
| CDR0000350313 | REGISTRY | None | None |
| NCI-6256 | Registry Identifier | PDQ Physician Data Query | None |