Docetaxel in Treating Older Patients With Locally Advanced or Metastatic 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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients. PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel. Secondary Determine the response rate in patients treated with this drug. Determine the overall survival and progression-free survival of patients treated with this drug. Determine the mood status and autonomy of activity of patients treated with this drug. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6 and 12 months after completion of study treatment. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Official Title
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Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: docetaxel
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of these histologies Stage IIIB (i.e., pleural T4) disease Stage IV disease Recurrent disease after prior surgery or radiotherapy allowed provided disease is in an area that was not previously irradiated Measurable disease by CT scan or MRI No symptomatic brain metastasis Activity of Daily Living Scale score ≥ 4 Instrumental Autonomy of Daily Living Scale score ≥ 4 PATIENT CHARACTERISTICS: Age 70 and over Performance status Not specified Life expectancy More than 3 months Hematopoietic Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 10 g/dL Hepatic Transaminases < 1.5 times normal Bilirubin normal Alkaline phosphatase < 2.5 times normal Pre-albumin > 1.5 mg/dL Renal Creatinine clearance > 30 mL/min Cardiovascular No congestive heart failure No unstable angina pectoris No myocardial infarction within the past year No uncontrolled hypertension No uncontrolled high-risk arrhythmias Gastrointestinal No active peptic ulcer No inflammatory bowel disease Neurologic No history of dementia or seizures that would preclude giving informed consent No peripheral neuropathy ≥ grade 2 No history of significant neurologic disorders Immunologic No history of hypersensitivity to the study drug or drugs formulated with polysorbate 80 No active uncontrolled infection Other No history of psychotic disorders No uncontrolled diabetes mellitus No absolute contraindication to corticosteroid use No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No geriatric depression scale score ≥ 12/15 No familial, social, geographical, or psychological reason that would preclude study follow up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for stage IIIB or IV non-small cell lung cancer No other concurrent chemotherapy Endocrine therapy No concurrent chronic treatment with corticosteroids except low-dose (i.e., methylprednisolone ≤ 20 mg/day or equivalent) treatment that was initiated > 6 months ago Radiotherapy See Disease Characteristics Surgery See Disease Characteristics Other More than 30 days since prior active participation in another therapeutic clinical trial No other concurrent anticancer therapy No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Mood status and autonomy of activity |  |  | 
| Toxicity |  |  | 

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