3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00064064|
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gemcitabine hydrochloride Drug: triapine||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer|
|Study Start Date :||January 2003|
|Study Completion Date :||August 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064064
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Tennessee|
|Sarah Cannon Cancer Center at Centennial Medical Center|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|