The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.
Biopsy-proven metastatic bladder cancer No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment 18 years of age and older
Exclusion Criteria:
Pure adeno- or squamous urothelial cancer Brain metastases that causes symptoms Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled
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For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. Dallas Texas, , United States
