A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium
- Registration Number
- NCT00949455
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lapatinib ditosylate is more effective than a placebo in killing tumor cells.
PURPOSE: This randomized phase II/III trial is studying how well lapatinib ditosylate works compared to a placebo in treating patients with stage IV bladder cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.
Secondary
* Compare overall survival between these patient groups.
* Evaluate the safety and tolerability of the regimens in these patients.
* Assess and compare quality of life between these patient groups.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status and response to first line chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.
Patients undergo quality of life assessment by EORTC QLQ-C30 at baseline and every 4 weeks during study treatment.
After completion of study treatment, patients are followed up periodically for up to 5 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I lapatinib ditosylate Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity. Arm II Placebo Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Progression free survival Disease Progression - at least 20% increase in the sum of longest diameters of target lesions.
- Secondary Outcome Measures
Name Time Method Overall survival
Trial Locations
- Locations (27)
Barts and the London NHS Trust
🇬🇧London, England, United Kingdom
NHS Grampian - Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Basildon and Thurrock University Hospital NHS Trust - Basildon Hospital
🇬🇧Basildon, United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Birmingham University Hospital
🇬🇧Birmingham, United Kingdom
Royal Bournemouth and Christchurch NHS Foundation Trust - Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
University Hospitals Bristol NHS Trust - Bristol University Hospital
🇬🇧Bristol, United Kingdom
Cambridge University Hospitals NHS Trust - Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Mid Essex NHS Trust - Broomfield Hospital
🇬🇧Chelmsford, United Kingdom
Colchester University Hospitals NHS Trust
🇬🇧Colchester, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom
Scroll for more (17 remaining)Barts and the London NHS Trust🇬🇧London, England, United Kingdom