Clinical trial NCT00871403: Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer
Official title: An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer, Non-Small Cell
Keywords: GW786034
pazopanib
pemetrexed
cisplatin
non-small cell lung cancer
NSCLC
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Randomization until progression or death (up to 85 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization until death (up to 85 weeks)
measure: Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
timeFrame: Randomization until response or progressive disease (up to 85 weeks)
measure: Percentage of Participants With a Complete Response or a Partial Response
timeFrame: Randomization until response or progressive disease (up to 85 weeks)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: GSK Investigational Site
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: