A trial looking at lapatinib versus a placebo for people with bladder cancer that has spread to other parts of the body.
- Conditions
- The medical condition being investigated in this trial is locally advanced or metastatic urological cancer. The tumour must overexpress HER1 and/or HER2 gene.MedDRA version: 17.1 Level: PT Classification code 10005012 Term: Bladder cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-001826-28-GB
- Lead Sponsor
- Queen Mary University London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 232
•Histologically confirmed metastatic or locally advanced transitional cell carcinoma of the urothelium.
•Stage IV disease at entry of the study
•Able to commence study treatment within 10 weeks of completing chemotherapy
•HER1-positive (2+ or 3+ intensity on immunohistochemical staining (IHC) and/or amplification of the HER1 gene on fluorescence in situ hybridization (FISH)) and/or HER2-positive (2+ or 3+ intensity on immunohistochemical staining (IHC) and/or amplification of the HER2 gene on FISH)
•Objective response or stable disease following at least 4 and no more than 8 cycles of first-line chemotherapy. The chemotherapy regimen includes any widely accepted regimen for bladder cancer. Patients who do not receive cisplatin remain eligible. Dose reduction and delays in treatment between cycles are acceptable.
•Adequate haematological function (ANC =1.0 x 109/l, Hb = 8.0 g/dL and platelet count to =75 x 109/l).
•Adequate liver function tests (ALT/AST < 2 x ULN, bilirubin level < 1.5 x ULN).
•Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram)
•ECOG performance status 0-3
•Age = 18 years
•If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
•Written informed consent prior to admission to this study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
•Patients who progress by RECIST on first-line chemotherapy and require 2nd line chemotherapy. Patients with progression of disease who do not fulfil RECIST criteria for PD and do not require 2nd line therapy are eligible. The original pre-treatment CT and post treatment CT should be compared to assess response.
•More than one line of prior chemotherapy for metastatic or locally advanced disease (Neoadjuvant/adjuvant chemotherapy is acceptable).
•Serum creatinine concentration > 3.0 x ULN and/or creatinine clearance <30 ml/min (using EDTA or Cockcroft and Gault)
•Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
•Previous treatment with study medication and/or known hypersensitivity to the study medication.
•Past or current history of other neoplasms, except for:
o Any non life-threatening tumours that have been curatively treated.
•Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure >115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
• Serious intercurrent medical or psychiatric illness, including serious active infection
• Concurrent treatment with other experimental drugs.
• Less than 4 cycles or more than 8 cycles of standard chemotherapy
•Greater than 10 week delay from finishing 1st line chemotherapy to starting maintenance therapy.
• Pregnant or nursing women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method