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

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