Carcinoma, Transitional Cell
Conditions
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 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.
Interventions
DRUGPemetrexed
DRUGGemcitabine
DRUGPlatinol
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity will be measured by standard grading methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST). | — |
| Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause. | — |
| Time to progressive disease is defined as time from enrollment to first date of disease progression. | — |
| Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment. | — |
| Survival time is defined as time from enrollment to death from any cause. | — |
Countries
United States
Outcome results
None listed