Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00278460|
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : January 19, 2017
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel 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: docetaxel Drug: gemcitabine hydrochloride||Phase 2|
- Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
- Determine the overall and progression-free survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer|
|Study Start Date :||November 2000|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||September 2007|
- Drug: docetaxel
40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days
- Drug: gemcitabine hydrochloride
800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.
- patient response rate to weekly taxotere and gemcitabine [ Time Frame: 6 weeks ]
- Evaluate toxicity of weekly Taxotere and Gemcitabine [ Time Frame: 6 weeks ]
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): NCT00278460
|Study Chair:||Antonius A. Miller, MD||Wake Forest University Health Sciences|