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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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: Positive cytology 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic AST and ALT normal Bilirubin normal Renal Creatinine clearance ≥ 50 mL/min Immunologic No known HIV positivity No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No clinically significant active infection Other 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: Biologic 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 Chemotherapy No prior cytotoxic chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy for the malignancy Radiotherapy 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 Surgery No concurrent surgery for the malignancy Other 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel and Cisplatin<br>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. | Drug: cisplatin<br> <br> Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Tumor Response Rate | 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. | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progressive Disease | 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. | 8 years | 
| 1-year Survival Rate |  | 1 year | 
| Median Survival Time |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer