Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
- Registration Number
- NCT00118131
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel and Cisplatin cisplatin A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15. Docetaxel and Cisplatin docetaxel A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
- Primary Outcome Measures
Name Time Method Overall Tumor Response Rate 7 years 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.
- Secondary Outcome Measures
Name Time Method 1-year Survival Rate 1 year Median Survival Time 10 years Time to Progressive Disease 8 years 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.
Trial Locations
- Locations (13)
UMDNJ - University Hospital
🇺🇸Newark, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
JFK Medical Center in Edison
🇺🇸Edison, New Jersey, United States
Raritan Bay Medical Center
🇺🇸Perth Amboy, New Jersey, United States
Central Jersey Oncology Center, PA - East Brunswick
🇺🇸East Brunswick, New Jersey, United States
CentraState Medical Center
🇺🇸Freehold, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸Hamilton, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Mountainside Hospital Cancer Center
🇺🇸Montclair, New Jersey, United States
Somerset Medical Center
🇺🇸Somerville, New Jersey, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States