Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer Read More

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