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

OBJECTIVES:

Primary

• Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
• Determine the overall and progression-free survival of patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.

Secondary

• Determine the duration of response in patients treated with this regimen.

OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.

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