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

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types:
• •* Squamous cell carcinoma
• •* Adenocarcinoma, including bronchoalveolar cell adenocarcinoma
• •* Large cell anaplastic carcinoma, including giant and clear cell carcinomas
• •Histologic or cytologic documentation of recurrence is required
• •Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging
• •* The following lesions are not considered measurable or evaluable:
• •* Bone disease only
• •* Pleural or pericardial effusions
• •* Previously irradiated lesions, unless subsequent progression is documented
• •CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry
• •PATIENT CHARACTERISTICS:
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •Negative pregnancy test
• •CALGB performance status ≤ 1
• •Life expectancy ≥ 3 months
• •Granulocyte count \> 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Creatinine ≤ 2 times normal
• •Bilirubin normal
• •SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR
• •Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal
• •Ejection fraction normal by ECHO or MUGA
• •No history of congestive heart failure
• •No psychiatric illness that would preclude study compliance
• •No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to \< 3 months
• •No active uncontrolled bacterial, fungal, or viral infection
• •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy
• •No pre-existing peripheral neuropathy ≥ grade 2
• •PRIOR CONCURRENT THERAPY:
• •At least 2 weeks since prior major surgery and recovered from acute effects
• •At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects
• •* Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed
• •No prior chemotherapy
• •No concurrent cranial or thoracic radiation therapy
• •No concurrent cytotoxic or hormonal therapy
• •Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction