Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer
Condition: Lung Cancer, Non-Small Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pazopanib and pemetrexed; pemetrexed and cisplatin
Intervention description: oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m^2 once every 3 weeks, then pazopanib 800 mg once daily; pemetrexed IV 500 mg/m^2 and cisplatin IV 75 mg/m^2 once every 3 weeks
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GW786034; pazopanib; pemetrexed; cisplatin; non-small cell lung cancer; NSCLC

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