3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00077415|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : May 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gemcitabine hydrochloride Drug: triapine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||February 2008|
U.S. FDA Resources
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077415
|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|
|National University of Singapore|
|Singapore, Singapore, 119260|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Johns Hopkins Singapore International Medical Centre|
|Singapore, Singapore, 308433|
|Study Chair:||Brigette Ma, MD||Prince of Wales Hospital|