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Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067464

NCT ID:

NCT00004223

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • stage III bladder cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • posterior urethral cancer
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • regional transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - ClevelandCleveland, Ohio  44106
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
CCOP - Sooner StateTulsa, Oklahoma  74136
Overlook HospitalSummit, New Jersey  07902-0220
Kimball Medical CenterLakewood, New Jersey  08701
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197