Status:
COMPLETED
Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Carcinoma, Transitional Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00101842
Start Date
December 1 2004
End Date
July 1 2006
Last Update
August 29 2006
Active Locations (1)
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1
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