Gemcitabine and Carboplatin Followed by Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

• Determine the efficacy and tolerability of gemcitabine hydrochloride and carboplatin followed by paclitaxel in patients with stage IIIB-IV non-small cell lung cancer in regard to response rate, median survival, and one year survival.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is multicenter study.

• Part 1: Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. In week 7, all patients proceed to part 2 regardless of disease response.
• Part 2: Patients receive paclitaxel IV over 1-3 hours once weekly for 6 weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small lung cancer (NSCLC) of any of the following histologic types:

• Squamous cell
• Adenocarcinoma
• Large cell carcinoma
• Unspecified
• Evidence of at least 1 of the following criteria:

• Newly diagnosed inoperable stage IIIB (pleural effusion) disease
• Patients with stage III disease who are unable to undergo combined modality therapy
• Stage IV disease
• Recurrent non-small cell lung cancer regardless of site
• Diagnosis based on sputum cytology acceptable if confirmed by an independent pathologic review
• Patients must have measurable or evaluable disease

• Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present
• Patients with brain metastases are eligible, provided they are either asymptomatic (no neurological symptoms or signs, no evidence of midline shift), or controlled (i.e., after surgical resection or radiotherapy/radiosurgery), and off all steroid therapy for at least two weeks with no evidence of progression by symptoms or radiologic imaging

PATIENT CHARACTERISTICS:

• ECOG performance status of 2 or 3 OR HIV-positive OR underwent prior status post organ transplantation
• No active serious infection (except for HIV infection)
• No symptomatic, untreated malignant pericardial effusion
• No congestive heart failure
• No other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment
• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm ^3
• Creatinine clearance ≥ 40 mL/min
• Creatinine ≤ 1.8 mg/dL
• Bilirubin < 1.5 mg/dL
• SGOT ≤ 2 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Males or females of reproductive potential may not participate unless they have agreed to use effective barrier contraceptive methods
• No prior malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior chemotherapy is not allowed
• At least three weeks since prior radiotherapy and recovered from all toxicities
• At least three weeks must have elapsed from major surgery and recovered from all adverse effects of surgery
• No prior colony-stimulating factors or interferon
• No concurrent hormonal, biologic, or radiotherapy to measurable lesions

• Patients may receive concurrent palliative radiotherapy to small-field nonmeasurable sites of disease (e.g., painful bony metastases)