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.
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 7.5-21 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Cancer Institute at National University Hospital
Objective tumor response as assessed by RECIST criteria
Toxicity as assessed by NCI CTCAE v3.0
Overall survival
Median time to progression
Duration of overall response
Pharmacokinetics
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Singapore, Singapore
National University of Singapore
Singapore, Singapore
National Cancer Centre - Singapore
Singapore, Singapore
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea