Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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.

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