3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Objective tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Median time to progression [ Designated as safety issue: No ]
- Duration of overall response [ Designated as safety issue: No ]
- Pharmacokinetics [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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 7.5-21 months.
|Australia, New South Wales|
|Sydney Cancer Centre at Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia, 2050|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital - Perth|
|Perth, Western Australia, Australia, 6009|
|Prince of Wales Hospital|
|Shatin, New Territories, Hong Kong|
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Cancer Institute at National University Hospital|
|Singapore, Singapore, 119074|
|Johns Hopkins Singapore International Medical Centre|
|Singapore, Singapore, 308433|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|National University of Singapore|
|Singapore, Singapore, 119260|
|Study Chair:||Brigette Ma, MD||Prince of Wales Hospital|