Expired Study
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Dallas, Texas


Purpose:

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.


Criteria:

Inclusion Criteria: - 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


NCT ID:

NCT00101842


Primary Contact:

Study Director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company


Backup Contact:

N/A


Location Contact:

Dallas, Texas
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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