A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium
NCT ID: NCT00949455
Last Updated: 2015-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
204 participants
INTERVENTIONAL
2009-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I
Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
lapatinib ditosylate
Given orally
Arm II
Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.
Placebo
Given orally
Interventions
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lapatinib ditosylate
Given orally
Placebo
Given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-3
* ANC ≥ 1.0 x 10\^9/L
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 75 x 10\^9/L
* ALT/AST \< 2 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Serum creatinine ≤ 3.0 ULN AND/OR creatinine clearance ≥ 30 mL/min
* LVEF ≥ 50% (as assessed by quantitative echocardiogram or MUGA)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No current active hepatic or biliary disease, except for any of the following:
* Gilbert's syndrome
* Asymptomatic gallstones
* Liver metastases
* Stable chronic liver disease per investigator assessment
* No known hypersensitivity to the study medication
* No history of prior or concurrent other neoplasms, except for:
* Any non life-threatening tumours that have been curatively treated.
* Prostate cancer isolated to the prostate gland
* No significant cardiac disease, including any of the following:
* Angina pectoris
* Severe cardiac arrhythmia requiring medication
* Severe conduction abnormalities
* Clinically significant valvular disease
* Cardiomegaly
* Prior myocardial infarction
* Ventricular hypertrophy
* Congestive heart failure
* Poorly uncontrolled hypertension (resting diastolic blood pressure \> 115 mm Hg)
* Other cardiomyopathy
* No serious intercurrent medical or psychiatric illness
* No serious active infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant/adjuvant chemotherapy allowed)
* No more than 10 weeks since first-line chemotherapy
* No prior lapatinib ditosylate
* No prior radiotherapy to the indicator lesion(s) (newly arising lesions in previously irradiated areas allowed)
* At least 14 days since prior and no concurrent CYP3A4 inducers, including but not limited to, any of the following:
* Antibiotics (all rifamycin class agents \[e.g., rifampicin, rifabutin, rifapentine\])
* Anticonvulsants (phenytoin, carbamazepine, barbiturates \[e.g., phenobarbital\])
* Oral glucocorticoids (cortisone \[\> 50 mg\], hydrocortisone \[\> 40 mg\], prednisone \[\> 10 mg\], methylprednisolone \[\> 8 mg\], dexamethasone \[\> 2 mg²\])
* St. John's wort or modafinil
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including but not limited to, any of the following:
* Antibiotics (clarithromycin, erythromycin, troleandomycin)
* Antifungals (itraconazole, ketoconazole, fluconazole \[\>150 mg daily\], voriconazole)
* Antiretrovirals/protease inhibitors (delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir)
* Calcium channel blockers (verapamil, diltiazem)
* Antidepressants (nefazodone, fluvoxamine)
* Gastrointestinal agents (cimetidine, aprepitant)
* Grapefruit, grapefruit juice
* At least 6 months since prior and no concurrent amiodarone
* No concurrent radical or curative therapy (radiotherapy or surgery) at the end of first-line treatment (palliative radiotherapy allowed)
* No other concurrent experimental or investigational drugs
* No other concurrent anticancer treatment, including cytotoxic or specific immune therapy
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Queen Mary University of London
OTHER
Principal Investigators
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Thomas Powles, MD, MRCP
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Locations
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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
Derby Hospitals NHS Trust - Royal Derby Hospital
Derby, , United Kingdom
NHS Greater Glasgow and Clyde - The Beatson
Glasgow, , United Kingdom
Calderdale and Huddersfield NHS Trust - Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
Ipswich Hospital NHS Trust
Ipswich, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Liverpool, , United Kingdom
Guys & St Thomas' Hospital NHS Trust - Guys Hospital
London, , United Kingdom
Imperial Healthcare NHS Trust
London, , United Kingdom
Royal Marsden NHS Trust
London, , United Kingdom
South Tees NHS Trust - James Cook University Hospital
Middlesbrough, , United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle, , United Kingdom
Northampton General Hospitals NHS Trust
Northampton, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Sherwood Forest Hospitals NHS Trust - Kings Mill Hospital
Nottingham, , United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Portsmouth, , United Kingdom
Barking, Havering and Redbridge NHS Trust - Queens Hospital
Romford, , United Kingdom
Taunton and Somerset NHS Trust - Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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Bellmunt J, Werner L, Bamias A, Fay AP, Park RS, Riester M, Selvarajah S, Barletta JA, Berman DM, de Muga S, Salido M, Gallardo E, Rojo F, Guancial EA, Bambury R, Mullane SA, Choueiri TK, Loda M, Stack E, Rosenberg J. HER2 as a target in invasive urothelial carcinoma. Cancer Med. 2015 Jun;4(6):844-52. doi: 10.1002/cam4.432. Epub 2015 Feb 26.
Other Identifiers
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OCTG-LaMB
Identifier Type: -
Identifier Source: secondary_id
BL-2007-02
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2007-001826-28
Identifier Type: -
Identifier Source: secondary_id
EU-20929
Identifier Type: -
Identifier Source: secondary_id
CDR0000640393
Identifier Type: -
Identifier Source: org_study_id
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