Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB 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, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen is more effective for non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unresectable stage IIIB or IV non-small cell lung cancer. Secondary Compare the overall survival of patients treated with these regimens. Compare the response rate in patients treated with these regimens. Compare the incidence of serious adverse events in patients treated with these regimens. Determine the quality of life of patients treated with these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion. Patients are followed at 1 month and then every 2-3 months thereafter. PROJECTED ACCRUAL: A total of 210-230 patients (105-115 per treatment arm) will be accrued for this study.

Official Title
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A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* 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 Unresectable stage IIIB or IV disease No untreated brain or leptomeningeal metastases Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment No symptomatic (i.e., requiring thoracentesis) pleural effusion No clinically significant (i.e., grade 3 or greater) pericardial effusion PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 (70 years of age and over) OR ECOG 2 (under 70 years of age) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No grade 2 or greater peripheral neuropathy No prior hypersensitivity reaction to taxanes or products containing polysorbate 80 No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less) No concurrent radiotherapy Surgery More than 3 weeks since prior major surgery Other More than 30 days since prior anticancer investigational drugs Concurrent supportive care investigational agents allowed

Ages Eligible for Study
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Minimum Age: 18 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<br> | Drug: docetaxel<br>* Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. OR Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion. Patients are followed at 1 month and then every 2-3 months thereafter.<br>* Other names: Docefrez;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 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