Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This is an interventional treatment trial for Malignant Pleural Effusion Read More

Inclusion Criteria:

• Histologic or cytologic diagnosis of non-small cell lung cancer
• At least one site of measurable disease, as defined by the modified RECIST criteria
• Stage IIIB with pleural effusion or Stage IV disease; includes patients who received surgery alone for early stage disease, now in relapse with advanced disease; staging is according to the American Joint Committee on Cancer classification scheme, 6th edition
• Total bilirubin < 1.25 x upper limit of normal (ULN)
• Baseline absolute neutrophil count >= 1500/uL
• Baseline platelet count >= 100,000/uL
• ECOG Performance Status 0, 1 or 2 at the time of informed consent
• Written, voluntary consent
• Patients with reproductive potential must use an acceptable contraceptive method, such methods include: 1) Male hormonal contraception; 2) Partner without reproductive potential, including post-menopausal status or history of tubal ligation; 3) Partner with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5) Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse
• AST and ALT =< 2.5 x ULN
• Creatinine =< 1.5 x ULN

Exclusion Criteria:

• Uncontrolled brain metastasis; patients with known brain metastasis must have completed treatment with surgery, radiation or both; in addition, they must be off corticosteroids
• Symptomatic neuropathy (Grade 2 or higher)
• Prior chemotherapy for advanced non-small cell lung cancer (Prior adjuvant, neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence)
• Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
• Prior radiation therapy to > 25% of bone marrow
• Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial infarction within 6 months
• Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
• Patient has known chronic liver disease, e.g., diagnosis of chronic active hepatitis or cirrhosis
• Major surgery two weeks prior to study treatment
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
• Any condition requiring continuous administration of systemic corticosteroids
• The patient is on therapeutic anti-coagulation with warfarin
• The administration of any other anticancer agents including chemotherapy and biologic agents is NOT permitted
• The use of other concurrent investigational drugs is not allowed
• Participants in this study must avoid grapefruit juice or other grapefruit-containing products for the duration of treatment with imatinib