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

Phase 2
18 Years
Not Enrolling
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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




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



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CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Rochester Cancer Center Rochester, New York  14642
Ireland Cancer Center Cleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
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Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
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CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
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Medical College of Wisconsin Milwaukee, Wisconsin  53226
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Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Hunterdon Regional Cancer Center Flemington, New Jersey  08822
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
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