Clinical trial NCT00623064 (phase 1, status: completed)
Conditions: bladder cancer, transitional cell cancer of the renal pelvis and ureter
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: cisplatin, gemcitabine hydrochloride, lapatinib ditosylate
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven transitional cell carcinoma of the urothelial tract

               -  Metastatic or locally advanced disease

          -  Measurable disease according to RECIST

               -  Involvement of at least one target not in previously irradiated fields

          -  Overexpressing HER1 and/or HER2 receptors (HER2 3+ by IHC OR HER2 FISH or CISH
             positive)

          -  No clinical signs of CNS involvement

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-1

          -  ANC ≥ 1,500/mm³

          -  Thrombocytes > 100,000/mm³

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST/ALT ≤ 3 times ULN

          -  Creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective double-barrier contraception during and for 3
             months after completion of study treatment

          -  Cardiac ejection fraction normal

          -  Normal 12 lead ECG

          -  No serious cardiac illness or medical condition within the past 6 months including,
             but not limited to, any of the following:

               -  Documented congestive heart failure

               -  High-risk uncontrolled arrhythmias

               -  Angina pectoris requiring antianginal medication

               -  Clinically significant valvular heart disease

               -  Evidence of transmural infarction on ECG

               -  Poorly controlled hypertension (e.g., systolic blood pressure [BP] > 180 mm Hg or
                  diastolic BP > 100 mm Hg)

          -  No peripheral neuropathy > grade 1

          -  Able to swallow and retain oral medication

          -  No other malignancy within the past 3 years except basal cell or squamous cell
             carcinoma of the skin or carcinoma in situ of the cervix

          -  No active or uncontrolled infections, serious illnesses, malabsorption syndrome or
             medical conditions, hepatitis, HIV, and/or cirrhosis

          -  No psychological, familial, sociological, or geographical condition potentially
             hampering study protocol compliance or follow-up schedule

          -  No current active hepatic or biliary disease (with the exception of Gilbert's
             syndrome, asymptomatic gallstones, liver metastases or stable chronic liver metastases
             or stable chronic liver disease)

        PRIOR CONCURRENT THERAPY:

          -  Recovered from any effects of surgery

          -  Intravesicle therapy for superficial disease allowed

          -  Prior neoadjuvant or adjuvant chemotherapy allowed

               -  Must have a minimum interval of six months between the completion of neoadjuvant
                  or adjuvant chemotherapy and the diagnosis of metastatic disease

          -  No prior chemotherapy for metastatic disease

          -  No radiotherapy within the past 4 weeks

          -  No drugs and herbal inducers or inhibitors of CYP3A4 (e.g., bergamottin or glabridin)
             within 10 days prior to study treatment and while receiving lapatinib ditosylate
             therapy

          -  No other concurrent anticancer therapy or investigational agents

          -  No other concurrent anticancer agents

          -  No concurrent treatment with other investigational therapy for other diseases or
             conditions

          -  No concurrent prophylactic antibiotics

          -  No concurrent prophylactic filgrastim (G-CSF)

          -  At least 14 days since prior and no concurrent herbal or dietary supplements

          -  No concurrent consumption of grapefruit juice