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Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer Clinical research trials and Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer clinical trial. Human subjects often get the best healthcare available for their Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer  Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
For Condition: recurrent bladder cancer,stage 3 bladder cancer,metastatic transitional cell cancer of the renal pelvis and ureter,transitional cell carcinoma of the bladder,recurrent transitional cell cancer of the renal pelvis and ureter,regional transitional cell cancer of the renal pelvis and ureter,stage 4 bladder cancer
Status: No longer recruiting
Sponsor(s): Amgen ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JenniferTam, Study Chair, Amgen
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Arlington Cancer Center
Arlington, Texas, 76012
United States
Oncology-Hematology Associates of North Illinois, Ltd.
Gurnee, Illinois, 60031
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Hematology & Oncology Associates of Southern Michigan
Jackson, Michigan, 49201
United States
Hematology Oncology Associates of Central New York
Syracuse, New York, 13217-6962
United States
Memphis Cancer Center, Inc.
Memphis, Tennessee, 38119
United States
Sacramento Center for Hematology and Medical Oncology
Sacramento, California, 95819
United States
Northern Virginia Oncology Group
Fairfax, Virginia, 22031
United States
University of California San Diego
La Jolla, California, 92093
United States
St. Joseph Medical Center
Towson, Maryland, 21204
United States
Additional Information:
Study ID Numbers: CDR0000067939; NCI-V00-1594,AMGEN-GCSF-990125
Study Start Date: December 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005958
Other Stage 3 Bladder Cancer Studies:
1. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
2. Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
3. Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
4. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
5. Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer
Related Studies:
Other stage 3 bladder cancer Clinical Trials
Other Illinois Clinical Trials
Other Gurnee Clinical Trials
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
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