Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101842|
Recruitment Status : Completed
First Posted : January 17, 2005
Last Update Posted : August 29, 2006
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Transitional Cell||Drug: Pemetrexed Drug: Gemcitabine Drug: Platinol||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer|
|Study Start Date :||December 2004|
|Estimated Study Completion Date :||July 2006|
- Toxicity will be measured by standard grading methods.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101842
|United States, Texas|
|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|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|