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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871403
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : February 16, 2012
Last Update Posted : June 20, 2013
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Lung Cancer, Non-Small Cell Drug: pazopanib and pemetrexed Drug: pemetrexed and cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Investigational treatment (pazopanib and pemetrexed)
Drug: pazopanib and pemetrexed
oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m^2 once every 3 weeks, then pazopanib 800 mg once daily
Active Comparator: Arm 2
Standard treatment (pemetrexed and cisplatin)
Drug: pemetrexed and cisplatin
pemetrexed IV 500 mg/m^2 and cisplatin IV 75 mg/m^2 once every 3 weeks

Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Randomization until progression or death (up to 85 weeks) ]
    PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization until death (up to 85 weeks) ]
    OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.

  2. Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only [ Time Frame: Randomization until response or progressive disease (up to 85 weeks) ]
    Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.

  3. Percentage of Participants With a Complete Response or a Partial Response [ Time Frame: Randomization until response or progressive disease (up to 85 weeks) ]
    The percentage of participants with a complete response or a partial response was evaluated.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871403

GSK Investigational Site
Herlev, Denmark, 2730
United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00871403     History of Changes
Other Study ID Numbers: 111128
First Posted: March 30, 2009    Key Record Dates
Results First Posted: February 16, 2012
Last Update Posted: June 20, 2013
Last Verified: March 2012

Keywords provided by GlaxoSmithKline:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors