Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Histologic or cytologic proof of locally advanced or metastatic unresectable NSCLC, Patients with the pneumonic form of BAC, or cavitary lesions > 3.5 cm or with cavitary lesions of any size with air/fluid levels are not eligible.
No prior chemotherapy or biologic therapy for lung cancer
Measurable or evaluable pulmonary disease required
Age > 18 years
ECOG performance status of 0-1
Adequate bone marrow, hepatic, and renal function
Total bilirubin < ULN
SGOT and/or SGPT may be up to 2.5 x ULN if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4 x ULN if SGOT and SGPT are both ≤ ULN
Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min/1.7 m2 BSA

Patients must have the following pulmonary function test values:

DLCO > 50% predicted. (DLCO must be adjusted for the patient's hemoglobin)
FVC> 50% of predicted
FEV1 >50% of predicted
Resting oxygen saturation > 90%
Exercise oxygen saturation > 85%
Prior surgery is permitted provided full recovery has occurred
Patients may not have received prior radiotherapy to the lungs. Patients with only chest wall or breast irradiation are eligible provided there is no radiographic evidence of pulmonary damage attributed to radiation therapy. Patients who have undergone Radioactive Iodine (RAI) therapy are also eligible.
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Exclusion Criteria:

Women must not be pregnant or breast-feeding during this study. Men and women with reproductive potential must use an effective contraceptive method while on this study and agree to use an effective method for three months after completing chemotherapy.
Patients with large obstructive pulmonary lesions that may cause blockage of delivery of aerosolized drug to the affected lung, in the judgment of the treating physician. A ventilation scan is recommended if the status is unclear.
Patients with other active malignancies. Patients with a history of prior malignancy other than NSCLC must not have received chemotherapy within the past 5 years and may not have had prior therapy with mitomycin (> 25 mg/m2), bleomycin or nitrosoureas (> 200 mg/m2). The patient may not have had any indication of pulmonary toxicity from the chemotherapy.
Serious active infections which are not controlled such that the patient continues to manifest symptoms despite treatment
Patients with progressive extra-pulmonary metastases who are unlikely to benefit from systemic or inhaled chemotherapy, e.g., extensive liver metastases, untreated brain metastases or treated brain metastases which are not clinically stable. If patients have received radiation treatment for brain metastases, at least 3 weeks must have elapsed since the last treatment and the patient must have recovered from all toxicity, not be receiving corticosteroids and have stable neurologic function off corticosteroids.
Patients with known hypersensitivity to platinum compounds or taxanes or other drugs formulated with polysorbate 80
asthma
uncontrolled diabetes mellitus
Patients who have undergone lung transplantation
unstable angina, congestive heart failure, or symptomatic arrhythmias or any other serious illness or medical condition that in the judgment of the investigator compromises the patient's safety
clinically significant neuropathy (≥ Grade 1) by history or physical examination
Patients using other investigational drugs