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

Lilly

Status and phase

Completed

Phase 2

Phase 1

Conditions

Carcinoma, Transitional Cell

Treatments

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Platinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101842

H3E-US-S066

9439

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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