Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
Completed · Phase 1/Phase 2
Conditions studied: Carcinoma, Transitional Cell
In brief
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.
Key facts
- Study ID
- NCT00101842
- Run by
- Eli Lilly and Company
- People needed
- 61
- Starts
- 2004-12-01
- Expected to finish
- 2006-07-01
- Last updated by the study team
- 2006-08-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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