RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or advanced urothelium cancer.

Condition	Treatment or Intervention	Phase
stage III bladder cancer regional transitional cell cancer of the renal pelvis and ureter transitional cell carcinoma of the bladder recurrent bladder cancer stage IV bladder cancer recurrent transitional cell cancer of the renal pelvis and ureter metastatic transitional cell cancer of the renal pelvis and ureter	Drug: docetaxel  Drug: filgrastim  Drug: gemcitabine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Jennifer Tam,  Study Chair,  Amgen   

Study ID Numbers:  CDR0000067939; AMGEN-GCSF-990125; NCI-V00-1594
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005958
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08