Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
- 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
- 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
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
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall tumor response rate
Joseph Aisner, MD
Cancer Institute of New Jersey
United States: Federal Government
|Overlook Hospital||Summit, New Jersey 07902-0220|
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Saint Peter's University Hospital||New Brunswick, New Jersey 08901-1780|
|Somerset Medical Center||Somerville, New Jersey 08876|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Raritan Bay Medical Center||Perth Amboy, New Jersey 08861|
|Mountainside Hospital Cancer Center||Montclair, New Jersey 07042|
|CentraState Medical Center||Freehold, New Jersey 07728|
|Central Jersey Oncology Center, PA - East Brunswick||East Brunswick, New Jersey 08816|