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Sponsored by: |
Amgen |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005958 |
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 | Intervention | Phase |
---|---|---|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter |
Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim |
Study Start Date: | October 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, California | |
Sacramento Center for Hematology and Medical Oncology | |
Sacramento, California, United States, 95819 | |
University of California San Diego | |
La Jolla, California, United States, 92093 | |
United States, District of Columbia | |
Washington Cancer Institute | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Center for Hematology-Oncology | |
Boca Raton, Florida, United States, 33486 | |
United States, Illinois | |
Oncology-Hematology Associates of North Illinois, Ltd. | |
Gurnee, Illinois, United States, 60031 | |
United States, Maine | |
Maine Center for Cancer Medicine and Blood Disorders | |
Scarborough, Maine, United States, 04074 | |
United States, Maryland | |
St. Joseph Medical Center | |
Towson, Maryland, United States, 21204 | |
United States, Michigan | |
Hematology & Oncology Associates of Southern Michigan | |
Jackson, Michigan, United States, 49201 | |
United States, New York | |
Hematology Oncology Associates of Central New York | |
Syracuse, New York, United States, 13217-6962 | |
United States, Tennessee | |
Memphis Cancer Center, Inc. | |
Memphis, Tennessee, United States, 38119 | |
United States, Texas | |
Arlington Cancer Center | |
Arlington, Texas, United States, 76012 | |
United States, Virginia | |
Northern Virginia Oncology Group | |
Fairfax, Virginia, United States, 22031 |
Study Chair: | Jennifer Tam | Amgen |
Study ID Numbers: | CDR0000067939, AMGEN-GCSF-990125, NCI-V00-1594 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005958 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Docetaxel Renal Cancer Urologic Diseases Kidney Neoplasms Kidney Diseases Bladder Neoplasm |
Gemcitabine Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Antiviral Agents Immunosuppressive Agents Recurrence Carcinoma Radiation-Sensitizing Agents Ureteral Neoplasms Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Docetaxel Neoplasms by Site Urologic Diseases Kidney Neoplasms |
Therapeutic Uses Kidney Diseases Gemcitabine Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Ureteral Neoplasms Neoplasms, Glandular and Epithelial |