Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00182806|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 6, 2012
RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride||Phase 2|
- Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine.
- Determine the median time to progression in patients treated with this regimen.
OUTLINE: This a non-randomized, open-label, multicenter study.
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 month and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||July 2008|
Drug: gemcitabine hydrochloride
- Objective response (complete, partial, and stable disease)
- Median time to progression
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): NCT00182806
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Nithya Ramnath, MD||Roswell Park Cancer Institute|