NCT00118131

Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	docetaxel

Timeline

• Start date: 2003-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2005-07-11
• Last updated: 2023-08-15
• Results posted: 2013-11-25

Locations

13 sites across 1 country: United States