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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer

Conditions
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Carcinoma, Transitional Cell

Intervention / Treatment
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* Drug: Pemetrexed
* Drug: Gemcitabine
* Drug: Platinol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|
|Drug: Gemcitabine|nan|
|Drug: Platinol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity will be measured by standard grading methods. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  |