Condition category
Cancer
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Charlotte Rofe

ORCID ID

Contact details

ECMC
Barts and the London School of Medicine and Dentistry
Old Anatomy Building
Charterhouse Square
London
EC1M 6BQ
United Kingdom

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 on 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 measures

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

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

http://www.qmul.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes