Bladder Cancer Clinical Trial

Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer

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 tumor cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.

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Full Description

OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven progressive regional or metastatic transitional cell carcinoma of the urothelium or mixed histology containing a component of transitional cell carcinoma Failure of only 1 prior chemotherapy regimen for metastatic disease or in the adjuvant or neoadjuvant setting (not containing taxane or gemcitabine) Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR SGOT less than 1.5 times ULN AND alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No American Heart Association class III or IV heart disease No uncontrolled congestive heart failure No severe cardiac arrhythmias Neurologic: No sensory neuropathy grade 3 or 4 No prior peripheral neuropathy grade 2 or worse Other: No active unresolved infection being treated with parenteral antibiotics within the past 7 days No other malignancy within the past 5 years except: Curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Clinically unsuspected, organ confined prostate cancer found during cystoprostatectomy Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy Prior intravesical BCG allowed Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Study ID:

NCT00004223

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 72 Locations for this study

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CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte California, 91010, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto California, 94304, United States
Stanford University Medical Center
Stanford California, 94305, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver Colorado, 80209, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Veterans Affairs Medical Center - Gainsville
Gainesville Florida, 32608, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21231, United States
New England Medical Center Hospital
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth New Jersey, 07201, United States
Hunterdon Regional Cancer Center
Flemington New Jersey, 08822, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Kimball Medical Center
Lakewood New Jersey, 08701, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly New Jersey, 08060, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Riverview Medical Center - Booker Cancer Center
Red Bank New Jersey, 07701, United States
Overlook Hospital
Summit New Jersey, 07902, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn New York, 11209, United States
Veterans Affairs Medical Center - New York
New York New York, 10010, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Veterans Affairs Medical Center - Cleveland
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
CCOP - Sooner State
Tulsa Oklahoma, 74136, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Hahnemann University Hospital
Philadelphia Pennsylvania, 19102, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh Pennsylvania, 15240, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57105, United States
Veterans Affairs Medical Center - Nashville
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
MBCCOP - San Juan
San Juan , 00927, Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan , 00927, Puerto Rico
Pretoria Academic Hospitals
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Study ID:

NCT00004223

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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