CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study

Inclusion Criteria

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