Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC)

• Documented clinical or radiologic disease progression on or after initial systemic therapy

  • Must have received 1 prior platinum-based systemic therapy for NSCLC
• Measurable or nonmeasurable disease
• No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

• 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:

  • No prior systemic chemotherapy as a radiosensitizer combined with radiotherapy
  • Obtained stable neurologic function 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 0-2

Life expectancy

• Al least 16 weeks

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)
• Alkaline phosphatase no greater than 2.5 times ULN
• AST or ALT no greater than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No unstable angina
• No myocardial infarction within the past 6 months
• No evidence of cardiac conduction abnormalities (e.g., bundle branch block or heart block) unless cardiac status stable for the past 6 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of unstable neurological symptoms in the past 4 weeks (2 weeks for neurological symptoms due to brain metastases)
• No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide)
• No other unstable medical conditions
• No clinically significant active infection
• No neuropathy greater than grade 1
• No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer
• No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior polyglutamate paclitaxel
• No prior docetaxel

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior major surgery

Other

• Recovered from prior therapy
• More than 2 weeks since prior treatment for NSCLC
• More than 4 weeks since prior investigational drugs
• No other concurrent investigational drugs
• No other concurrent systemic antitumor therapy
• No concurrent amifostine
• Concurrent bisphosphonates allowed