Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder

Inclusion Criteria: * Histologically or cytologically confirmed transitional cell carcinoma of the urothelium (also called urothelial cancer); mixed histologies are allowed as long as the predominant histology is TCC; in addition, tumor tissue must be available for evaluation for EGFR and HER2/neu status * Locally recurrent or advanced, non-resectable or stage IV transitional cell carcinoma * Must have had prior platinum salt-based chemotherapy for TCC; other prior systemic chemotherapeutic or investigational treatment regimens for TCC are allowed; patient may have had up to three lines of chemotherapy for advanced disease; may have had paclitaxel provided their cancer did not progress while on it, and it was part of an adjuvant or neoadjuvant regimen; prior targeted or biological therapy is permitted except for drugs targeting EGFR and/or HER2; specifically, subjects must meet one or more of the following criteria: (a). Progression after treatment with a regimen that includes a platinum salt (e.g. carboplatin or cisplatin) for Stage IV or recurrent disease OR (b). Disease recurrence within two years (from the date of last dose of chemotherapy or surgery until day the informed consent is signed) of neoadjuvant or adjuvant treatment with a regimen that includes a platinum salt * Measurable or evaluable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; if all sites of measurable or evaluable disease have been irradiated, one site must have demon…