Clinical trial NCT00005958: Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
Official title: Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Sacramento
country: United States
facility: Sacramento Center for Hematology and Medical Oncology
state: California
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Boca Raton
country: United States
facility: Center for Hematology-Oncology
state: Florida
city: Gurnee
country: United States
facility: Oncology-Hematology Associates of North Illinois, Ltd.
state: Illinois
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders
state: Maine
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Jackson
country: United States
facility: Hematology & Oncology Associates of Southern Michigan
state: Michigan
city: Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: Memphis
country: United States
facility: Memphis Cancer Center, Inc.
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Northern Virginia Oncology Group
state: Virginia
Study officials:
affiliation: Amgen
name: Jennifer Tam
role: STUDY_CHAIR
References: