Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: cisplatin intervention 2: docetaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: