Double Blind Randomized Phase III Study of Maintenance Pazopanib Versus Placebo in NSCLC Patients Non Progressive After First Line Chemotherapy. MAPPING, an EORTC Lung Group Study.
OBJECTIVES:
Primary
- To compare the therapeutic benefit, in terms of overall survival, of maintenance
pazopanib hydrochloride in patients with non-small cell lung cancer who have not
progressed after first-line chemotherapy.
Secondary
- To compare progression-free survival (PFS) overall and at specific time points (6 and
12 months).
- To document the toxicity profile of pazopanib hydrochloride according to the CTCAE v 4.
- To assess the use of C-reactive protein (CRP) in the detection of progression of
disease in the maintenance phase of therapy.
- To compare quality-of-life of patients on maintenance therapy.
- To compare discontinuation rate/treatment compliance of patients treated with these
regimens.
- To collect health economics data on resource utilization as documented by the EQ-5D
generic QoL instrument.
Tertiary (correlative)
- To evaluate the effect of germline genetic variations on drug response
(pharmacogenetics) using PAX gene.
- To find relevant biomarkers of VEGFR pathways from plasma samples.
- To obtain the pharmacokinetics of pazopanib hydrochloride at 600 and 800 mg.
- To evaluate biomarkers in tumor tissue.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
center, histology (squamous vs nonsquamous), performance status (0-1 vs 2 up to 15% of
patients), and response to initial chemotherapy (complete response/partial response vs
stable disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive an oral placebo daily on days 1-28. Treatment repeats every 4
weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment
repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of life-questionnaires (QLQ-C30 and QLQ-LC13) at baseline, 6
weeks, 14 weeks, and 22 weeks.
Health economics data on resource utilization are collected and documented using the EQ-5D
questionnaire.
Blood samples may be collected periodically for pharmacokinetics and pharmacogenetic
studies. Samples are analyzed for germline genetic variations on drug response, relevant
biomarkers of VEGFR pathways, and concentration of pazopanib hydrochloride. Previously
collected tumor tissue is analyzed for biomarkers.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months thereafter.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival
No
Mary O'Brien, MD
Principal Investigator
Royal Marsden NHS Foundation Trust
Belgium: Federal Agency for Medicinal Products and Health Products
EORTC-08092
NCT01208064
July 2011
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