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

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Centre Medico-Chirurgical de Creil
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
- Centre Hospitalier Intercommunal St. Aubin les Elbeuf
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- Institut Curie Hopital
- Clinique De Genolier
- Charing Cross Hospital
- Centre for Cancer Research and Cell Biology at Belfast City Hospital
- West of Scotland Cancer Centre