Pazopanib Hydrochloride or a Placebo in Treating Patients With Non-Small Cell Lung Cancer Who Have Received First-Line Chemotherapy
- Conditions
- Lung Cancer
- Interventions
- Other: laboratory biomarker analysisOther: pharmacogenomic studiesOther: pharmacological studyProcedure: quality-of-life assessment
- Registration Number
- NCT01208064
- Brief Summary
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pazopanib hydrochloride is more effective than a placebo in treating patients with non-small cell lung cancer that has not progressed after first-line chemotherapy.
PURPOSE: This randomized phase II/III trial is studying how well giving pazopanib hydrochloride works and compares it with giving a placebo in treating patients with non-small cell lung cancer who have received first-line chemotherapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pazopanib pazopanib hydrochloride 2 weeks at 600mg and then maintenance at 800mg Placebo pharmacological study placebo match 2 weeks at 600mg and then maintenance at 800mg Placebo quality-of-life assessment placebo match 2 weeks at 600mg and then maintenance at 800mg Pazopanib quality-of-life assessment 2 weeks at 600mg and then maintenance at 800mg Placebo laboratory biomarker analysis placebo match 2 weeks at 600mg and then maintenance at 800mg Pazopanib pharmacological study 2 weeks at 600mg and then maintenance at 800mg Placebo pharmacogenomic studies placebo match 2 weeks at 600mg and then maintenance at 800mg Pazopanib laboratory biomarker analysis 2 weeks at 600mg and then maintenance at 800mg Pazopanib pharmacogenomic studies 2 weeks at 600mg and then maintenance at 800mg
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) overall and at 6 and 12 months Correlation of C-reactive protein with PFS at weeks 6, 14, and 22 Toxicity Health economics Quality of life Comparison of discontinuation rate with treatment compliance
Trial Locations
- Locations (21)
Klinik Loewenstein
🇩🇪Loewenstein, Germany
University General Hospital Heraklion
🇬🇷Heraklion, Greece
UniversitaetsMedizin Mannheim
🇩🇪Mannheim, Germany
Western General Hospital
🇬🇧Edinburgh, United Kingdom
University Clinic Golnik
🇸🇮Golnik, Slovenia
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Guy's and St Thomas' NHS
🇬🇧London, United Kingdom
Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
King's Mill Hospital
🇬🇧Sutton-in-Ashfield, United Kingdom
Clinique et Maternité Sainte Elisabeth
🇧🇪Namur, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Centre Hospitalier Regional De La Citadelle
🇧🇪Liege, Belgium
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
🇳🇱Amsterdam, Netherlands
National Cancer Institute
🇪🇬Cairo, Egypt
Centre Georges-Francois-Leclerc
🇫🇷Dijon, France
Isala Klinieken
🇳🇱Zwolle, Netherlands
Assistance Publique - Hôpitaux de Marseille - Assistance Publique - Hôpitaux de Marseille - Hopital Nord
🇫🇷Marseille, France
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom