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Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer Clinical research trials and Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer  Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
For Condition: posterior urethral cancer,recurrent bladder cancer,stage 3 bladder cancer,transitional cell carcinoma of the bladder,regional transitional cell cancer of the renal pelvis and ureter,stage 4 bladder cancer,metastatic transitional cell cancer of the renal pelvis and ureter
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDreicer, Study Chair, Eastern Cooperative Oncology Group
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
United States
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, 44106
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Additional Information:
Study ID Numbers: CDR0000067464; E-2899
Study Start Date: December 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004223
Other Posterior Urethral Cancer Studies:
1. Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
2. ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
3. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
4. Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
5. Celecoxib in Treating Patients With Bladder Cancer
Related Studies:
Other posterior urethral cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
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