Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer
(NSCLC)

- Cytologic specimens obtained by brushings, washings, or needle aspiration of a
defined lesion or from a pleural effusion are acceptable; sputum cytology alone
is not acceptable for determining cell type

- Must meet one of the following criteria:

- Recurrent disease following completion of radiation or surgery

- Stage IIIB disease and not a candidate for combined modality therapy (primary
radiation therapy or surgery)

- Stage IV disease

- Patients may have either measurable or nonmeasurable disease according to RECIST
criteria

- Baseline estradiol > 30 pg/mL

- Patients on hormone replacement therapy are eligible provided baseline estradiol
> 30 pg/mL

- Patients with known brain metastases must have received standard antitumor treatment
(e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS
metastases as defined by the site's institutional standards

- Neurologic function must have been stable for 2 weeks before randomization and
patients must either be off steroid therapy for their brain metastases or on a
tapering regimen

- Patients must have recovered from therapy for their brain metastases with no
evidence of significant unstable neurological symptoms within the 4 weeks before
study randomization

- No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology

PATIENT CHARACTERISTICS:

- Female

- ECOG performance score 0-2

- Life expectancy ≥ 12 weeks

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or
other hereditary bilirubin defects may be included regardless of bilirubin levels)

- SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN [CTC grade 0 to 2] if
due to liver metastases)

- Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with
laboratory documentation that demonstrates bone origin

- No pregnant women or nursing mothers

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No known hypersensitivity to study drugs or excipients

- Meets all of the following criteria:

- No weight loss > 10% in previous 6 months

- Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight
loss

- LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months

- BMI ≤ 35

- No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin
cancer

- No neuropathy grade 2 or greater

- No clinically significant active infection for which active therapy is underway

- No unstable medical conditions including unstable angina or myocardial infarction
within the past 6 months

- Patients with evidence of cardiac conduction abnormalities are eligible if their
cardiac status is stable

- No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from major surgery

- At least 7 days since prior local palliative radiotherapy

- At least 30 days since prior radiation therapy with curative intent

- At least 4 weeks since prior investigational therapy, unless local requirements are
more stringent

- No prior systemic chemotherapy for the treatment of lung cancer, including systemic
radiosensitizers used to treat brain metastases or any biologic agents

- No concurrent non-protocol-specified systemic antitumor therapy

- No concurrent amifostine, investigational agents, other cytotoxic agents for this
disease

- No concurrent radiotherapy (with the exception of radiotherapy for brain or bone
metastases for palliative purposes or radiotherapy for a condition other than NSCLC
that was ongoing at the time of randomization)

- Patients receiving palliative radiotherapy (treatment for symptomatic metastatic
disease) may be treated while on study