Plain English Summary
Trial website
Additional identifiers
EudraCT number
2007-001826-28
ClinicalTrials.gov number
NCT00949455
Protocol/serial number
5660
Study information
Scientific title
A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after first-line chemotherapy in patients with HER1 and/or HER2 overexpressing locally advanced or metastatic bladder cancer
Acronym
LaMB
Study hypothesis
Metastatic bladder cancer is treated with platinum analogue based chemotherapy. In this study patients will initially be treated with standard chemotherapy for locally advanced and metastatic bladder cancer. Those patients who have either a response to treatment (Response Evaluation Criteria in Solid Tumours [RECIST] criteria) or stabilisation of disease will go onto the study. Only those patients who are HER1 and/or HER2 positive will be eligible, as previous studies have shown that these individuals are most likely to respond to treatment with lapatinib. Patients will be randomised to receive maintenance therapy with either lapatinib or placebo. Therapy will continue until disease progression, excessive toxicity or patient request, at which point the treatment will be stopped and patients will be treated according to the doctor's discretion.
Ethics approval
South East Research Ethics Committee, 28/11/2007, ref: 07/H1102/73
Study design
Randomised multicentre double-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Bladder Cancer; Disease: Bladder (advanced)
Intervention
1. Lapatinib
2. Placebo
Dosage given = 1500 mg (6 x 250 mg tablets) per day. Patients will receive treatment until progression of disease. Follow up is continued at doctor's discretion until death.
Intervention type
Drug
Phase
Phase II/III
Drug names
Lapatinib
Primary outcome measure
Compare progression-free survival (PFS) in patients with HER1 and/or HER2 over expressing stage IV b, measured after the last follow up of the last patient.
Secondary outcome measures
Measured after the last follow up of the last patient:
1. To compare overall survival (OS) between the two groups
2. Evaluate the safety and tolerability
Overall trial start date
31/10/2008
Overall trial end date
01/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed metastatic or locally advanced stage IV transitional cell carcinoma of the urothelium
2. Able to commence study drug 3 - 8 weeks after completion of 1st line chemotherapy for metastatic bladder cancer
3. HER1 and/or HER 2 positive, confirmed by central lab
4. Objective response or stable disease following 4 - 8 cycles of first-line chemotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
6. Left ventricular ejection fraction (LVEF) within normal range as measured by ECHO or MUGA
7. Written informed consent
8. Aged over 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 204
Participant exclusion criteria
1. Progression with first-line chemotherapy for metastatic disease
2. Previous anti-HER1 or HER2 therapy
3. More than one line of chemotherapy for metastatic or locally advanced disease
4. Significant cardiac disease
5. Patients receiving less than 4 or more than 8 cycles of chemotherapy before randomisation
6. Major surgery or curative radiotherapy after chemotherapy (palliative radiotherapy is allowed)
Recruitment start date
31/10/2008
Recruitment end date
01/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
ECMC, Barts and the London School of Medicine and Dentistry
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary, University of London (UK)
Sponsor details
5 Walden Street
Whitechapel
London
E1 2EF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (UK)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list