Lung Cancer Clinical Trial
Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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.
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.
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.
Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following:
Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with effusion/serum LDH ratio ≥ 0.6
Stage IV disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy
18 and over
At least 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL
AST and ALT normal
Creatinine clearance ≥ 50 mL/min
No known HIV positivity
No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
No clinically significant active infection
Not pregnant or nursing
Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment
No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
No other serious systemic disorder that would preclude study participation
No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor [EGFR]) allowed provided there is disease progression during therapy and patient has recovered
No concurrent immunotherapy
No concurrent prophylactic colony-stimulating factors
No concurrent interleukin-11
No prior cytotoxic chemotherapy
No other concurrent chemotherapy
No concurrent hormonal therapy for the malignancy
See Disease Characteristics
More than 28 days since prior radiotherapy and recovered
No prior radiotherapy to ≥ 25% of the bone marrow
No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy
No concurrent radiotherapy
No concurrent surgery for the malignancy
More than 3 weeks since prior investigational drugs
Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered
No other concurrent investigational or commercial agents or therapies for the malignancy
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There are 12 Locations for this study
East Brunswick New Jersey, 08816, United States
Edison New Jersey, 08818, United States
Freehold New Jersey, 07728, United States
Hamilton New Jersey, 08690, United States
Long Branch New Jersey, 07740, United States
Montclair New Jersey, 07042, United States
Neptune New Jersey, 07754, United States
New Brunswick New Jersey, 08903, United States
New Brunswick New Jersey, 08903, United States
Newark New Jersey, 07103, United States
Perth Amboy New Jersey, 08861, United States
Somerville New Jersey, 08876, United States
Summit New Jersey, 07901, United States
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