study of pazopanib and pemetrexed in advanced non-small cell lung cancer

Conditions: Lung Cancer, Non-Small Cell

Summary: the main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * written informed consent * at least 18 years old * histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell stage iiibwet (with confirmed malignant pleural effusion) or stage iv nsclc * no prior systemic first-line therapy for advanced nsclc * measurable disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 12 weeks * able to swallow and retain oral medication * adequate organ system function (hematological, hepatic, and renal) * non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or childbearing potential, and agrees to use adequate contraception. a male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study exclusion criteria: * active malignancy or any malignancy in the 3 years prior to first dose of study drug other than nsclc * central nervous system (cns) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated cns metastases * clinically significant gastrointestinal abnormalities * prolongation of corrected qt interval (qtc) \> 480 msecs * history of any one or more cardiovascular conditions within the past 6 months prior to randomization * poorly controlled hypertension * history of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months * major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer * evidence of active bleeding or bleeding diathesis * recent hemoptysis * endobronchial lesions and/or lesions infiltrating major pulmonary vessels * serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures * use of any prohibited medication * use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug * ongoing toxicity from prior anti-cancer therapy that is \>grade 1 and/or that is progressing in severity except alopecia * known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, pemetrexed, and/or cisplatin * inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study * inability or unwillingness to take folic acid, vitamin b12 supplementation, or dexamethasone * clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start * recent or concurrent yellow fever vaccination

Keywords: gw786034 pazopanib pemetrexed cisplatin non-small cell lung cancer nsclc