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