Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Gemcitabine; Pemetrexed

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