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Status:

UNKNOWN

A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium

Lead Sponsor:

Queen Mary University of London

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Bladder Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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 pla...

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 ditos...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    204 Patients enrolled

    Trial Details

    Trial ID

    NCT00949455

    Start Date

    March 1 2009

    Last Update

    April 15 2015

    Active Locations (27)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (27 locations)

    1

    Barts and the London NHS Trust

    London, England, United Kingdom, EC1M 6BQ

    2

    NHS Grampian - Aberdeen Royal Infirmary

    Aberdeen, United Kingdom

    3

    Basildon and Thurrock University Hospital NHS Trust - Basildon Hospital

    Basildon, United Kingdom

    4

    University Hospitals Birmingham NHS Foundation Trust - Birmingham University Hospital

    Birmingham, United Kingdom