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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

Official Title: Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency

Study ID: NCT00005644

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States

Albert Einstein Clinical Cancer Center, Bronx, New York, United States

James P. Wilmot Cancer Center, Rochester, New York, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

CCOP - Scott and White Hospital, Temple, Texas, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States

Contact Details

Name: David J. Vaughn, MD

Affiliation: Abramson Cancer Center at Penn Medicine

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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