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

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
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)
Sites / Locations
- Greenebaum Cancer Center at University of Maryland Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins