Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery
Stage IIIB and not a candidate for combined modality therapy
Stage IV
No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

Cytological diagnosis must be based on the following:

No cellular diagnosis by sputum cytology alone
Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable
Measurable or nonmeasurable disease

Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met:

Neurologic function stable for at least 2 weeks before study entry
Off steroid therapy or on a tapering regimen
Recovered from prior therapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin)

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

No unstable angina
No myocardial infarction within the past 6 months
Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry

Neurologic

See Disease Characteristics
No neuropathy greater than grade 1
No evidence of unstable neurologic symptoms within the past 4 weeks (2 weeks for neurologic symptoms due to brain metastases)

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
No clinically significant active infection
No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
No other unstable medical conditions
No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior systemic biologic agent for lung cancer

Chemotherapy

See Disease Characteristics
No prior systemic chemotherapy for lung cancer including radiosensitizing agents

Endocrine therapy

See Disease Characteristics

Radiotherapy

See Disease Characteristics
No concurrent radiotherapy

Surgery

See Disease Characteristics
Recovered from prior major surgery

Other

More than 12 weeks since prior participation in any research study or treatment with investigational drugs
Recovered from prior investigational therapy or stable for 4 weeks before study treatment
No other concurrent investigational drugs
No other concurrent systemic antitumor therapy
No concurrent amifostine
Concurrent bisphosphonates allowed