A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium (LaMB)
14 april 2015 uppdaterad av: Queen Mary University of London
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 [LaMB]
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
204
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Aberdeen, Storbritannien
- NHS Grampian - Aberdeen Royal Infirmary
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Basildon, Storbritannien
- Basildon and Thurrock University Hospital NHS Trust - Basildon Hospital
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Birmingham, Storbritannien
- University Hospitals Birmingham NHS Foundation Trust - Birmingham University Hospital
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Bournemouth, Storbritannien
- Royal Bournemouth and Christchurch NHS Foundation Trust - Royal Bournemouth Hospital
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Bristol, Storbritannien
- University Hospitals Bristol NHS Trust - Bristol University Hospital
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Cambridge, Storbritannien
- Cambridge University Hospitals NHS Trust - Addenbrooke's Hospital
-
Chelmsford, Storbritannien
- Mid Essex NHS Trust - Broomfield Hospital
-
Colchester, Storbritannien
- Colchester University Hospitals NHS Trust
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Coventry, Storbritannien
- University Hospitals Coventry & Warwickshire NHS Trust
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Derby, Storbritannien
- Derby Hospitals NHS Trust - Royal Derby Hospital
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Glasgow, Storbritannien
- NHS Greater Glasgow and Clyde - The Beatson
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Huddersfield, Storbritannien
- Calderdale and Huddersfield NHS Trust - Huddersfield Royal Infirmary
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Ipswich, Storbritannien
- Ipswich Hospital NHS Trust
-
Leicester, Storbritannien
- University Hospitals of Leicester NHS Trust
-
Liverpool, Storbritannien
- Clatterbridge Centre for Oncology NHS Trust
-
London, Storbritannien
- Imperial Healthcare NHS Trust
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London, Storbritannien
- Guys & St Thomas' Hospital NHS Trust - Guys Hospital
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London, Storbritannien
- Royal Marsden NHS Trust
-
Middlesborough, Storbritannien
- South Tees NHS Trust - James Cook University Hospital
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Newcastle, Storbritannien
- Newcastle Upon Tyne Hospitals NHS Trust
-
Northampton, Storbritannien
- Northampton General Hospitals NHS Trust
-
Nottingham, Storbritannien
- Nottingham University Hospitals NHS Trust
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Nottingham, Storbritannien
- Sherwood Forest Hospitals NHS Trust - Kings Mill Hospital
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Portsmouth, Storbritannien
- Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
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Romford, Storbritannien
- Barking, Havering and Redbridge NHS Trust - Queens Hospital
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Taunton, Storbritannien
- Taunton and Somerset NHS Trust - Musgrove Park Hospital
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England
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London, England, Storbritannien, EC1M 6BQ
- Barts and the London NHS Trust
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the bladder
- Stage IV disease
- Metastatic or locally advanced disease
HER1- and/or HER2-positive disease, defined by the following criteria:
- 2+ or 3+ intensity on IHC
- Able to commence the study treatment within 10 weeks of completing chemotherapy
Must have achieved objective response or stable disease following 4-8 courses of first-line chemotherapy
- No progression with first-line chemotherapy for metastatic disease
- Any widely accepted chemotherapy regimen for bladder cancer allowed
- Patients who did not receive cisplatin are eligible
PATIENT CHARACTERISTICS:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Arm I
Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
|
Ges oralt
Andra namn:
|
|
Placebo-jämförare: Arm II
Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.
|
Ges oralt
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Progression free survival
Tidsram: Disease Progression - at least 20% increase in the sum of longest diameters of target lesions.
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Disease Progression - at least 20% increase in the sum of longest diameters of target lesions.
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Sekundära resultatmått
Resultatmått |
|---|
|
Total överlevnad
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Thomas Powles, MD, MRCP, Queen Mary University of London
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2009
Primärt slutförande (Förväntat)
1 juli 2015
Studieregistreringsdatum
Först inskickad
29 juli 2009
Först inskickad som uppfyllde QC-kriterierna
29 juli 2009
Första postat (Uppskatta)
30 juli 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000640393
- OCTG-LaMB
- BL-2007-02
- EUDRACT-2007-001826-28
- EU-20929
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