Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
|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: NCT00005644|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 1, 2019
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: gemcitabine hydrochloride Drug: paclitaxel||Phase 2|
- Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency|
|Actual Study Start Date :||May 2000|
|Actual Primary Completion Date :||February 2003|
|Actual Study Completion Date :||June 15, 2007|
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): NCT00005644
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, New Jersey|
|Veterans Affairs Medical Center - East Orange|
|East Orange, New Jersey, United States, 07019|
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|James P. Wilmot Cancer Center|
|Rochester, New York, United States, 14642|
|United States, North Dakota|
|CCOP - Merit Care Hospital|
|Fargo, North Dakota, United States, 58122|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, South Dakota|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57104|
|United States, Texas|
|CCOP - Scott and White Hospital|
|Temple, Texas, United States, 76508|
|United States, Wisconsin|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay|
|Green Bay, Wisconsin, United States, 54301|
|CCOP - Marshfield Medical Research and Education Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226-3596|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)|
|Milwaukee, Wisconsin, United States, 53295|
|Study Chair:||David J. Vaughn, MD||Abramson Cancer Center of the University of Pennsylvania|