RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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 docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES: Primary * Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer. Secondary * Determine the duration of response in patients treated with this regimen. * Determine time to disease progression in patients treated with this regimen. * Determine the 1-year survival rate in patients treated with this regimen. * Determine the median survival time in patients treated with this regimen. * Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once 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. After completion of study treatment, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States
JFK Medical Center in Edison
Edison, New Jersey, United States
CentraState Medical Center
Overall Tumor Response Rate
Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Time frame: 7 years
Time to Progressive Disease
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 8 years
1-year Survival Rate
Time frame: 1 year
Median Survival Time
Time frame: 10 years
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Freehold, New Jersey, United States
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Hamilton, New Jersey, United States
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