Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
NCT ID: NCT00005958
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
docetaxel
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Principal Investigators
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Jennifer Tam
Role: STUDY_CHAIR
Amgen
Locations
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University of California San Diego
La Jolla, California, United States
Sacramento Center for Hematology and Medical Oncology
Sacramento, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Oncology-Hematology Associates of North Illinois, Ltd.
Gurnee, Illinois, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
St. Joseph Medical Center
Towson, Maryland, United States
Hematology & Oncology Associates of Southern Michigan
Jackson, Michigan, United States
Hematology Oncology Associates of Central New York
Syracuse, New York, United States
Memphis Cancer Center, Inc.
Memphis, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Northern Virginia Oncology Group
Fairfax, Virginia, United States
Countries
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Other Identifiers
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AMGEN-GCSF-990125
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1594
Identifier Type: -
Identifier Source: secondary_id
CDR0000067939
Identifier Type: -
Identifier Source: org_study_id