Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Lung Cancer, Non-Small Cell

Treatments

Drug: pemetrexed and cisplatin

Drug: pazopanib and pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871403

111128

Details and patient eligibility

About

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).

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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