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Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

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Trial Information

Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim


OBJECTIVES: I. Determine the efficacy of gemcitabine, docetaxel, and filgrastim (G-CSF) in
patients with locally recurrent or advanced transitional cell carcinoma of the urothelial
tract. II. Determine the toxicity of this regimen in these patients. III. Determine the
disease-free and overall survival of this patient population treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no). Patients receive gemcitabine IV over 30 minutes on days 1 and 8
and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF)
subcutaneously daily beginning on day 9 and continuing until blood counts recover. Treatment
continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable
toxicity. Patients who respond to treatment may undergo surgery and 6-8 weeks later receive
2 more courses of chemotherapy. Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 23-40 patients who have not received prior chemotherapy and 23
patients who have received prior chemotherapy will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven locally recurrent or advanced transitional
cell carcinoma (TCC) of the urothelial tract (bladder, renal pelvis, or ureter) or TCC
with squamous cell or glandular elements not amenable to curative treatment No pure
squamous cell carcinoma or adenocarcinoma Regional or distant metastases after
cystoprostatectomy No brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life
expectancy: At least 3 months Hematopoietic: No hemorrhagic disorder Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater
than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No known
sensitivity to any products to be administered or E. coli derived products No prior other
malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II
cancer in complete remission, or early stage prostate cancer (not currently being treated)
No illness or psychiatric condition that would preclude study or follow up Not previously
entered in this study No active uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy No
concurrent WBC transfusions Chemotherapy: No prior gemcitabine or docetaxel Other prior
chemotherapy allowed Prior intravesical therapy allowed No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to renal pelvis or
ureter allowed Surgery: See Disease Characteristics Cystoprostatectomy or
nephroureterectomy for localized TCC allowed Other: No prior investigational drugs No
other concurrent investigational therapy No concurrent acetaminophen for fever prophylaxis

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jennifer Tam

Investigator Role:

Study Chair

Investigator Affiliation:

Amgen

Authority:

United States: Federal Government

Study ID:

CDR0000067939

NCT ID:

NCT00005958

Start Date:

October 1999

Completion Date:

Related Keywords:

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

Name

Location
Arlington Cancer Center Arlington, Texas  76012
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
University of California San Diego La Jolla, California  92093
Washington Cancer Institute Washington, District of Columbia  20010
Northern Virginia Oncology Group Fairfax, Virginia  22031
Sacramento Center for Hematology and Medical Oncology Sacramento, California  95819
Center for Hematology-Oncology Boca Raton, Florida  33486
Oncology-Hematology Associates of North Illinois, Ltd. Gurnee, Illinois  60031
St. Joseph Medical Center Towson, Maryland  21204
Hematology & Oncology Associates of Southern Michigan Jackson, Michigan  49201
Hematology Oncology Associates of Central New York Syracuse, New York  13217-6962
Memphis Cancer Center, Inc. Memphis, Tennessee  38119