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Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium Clinical research trials and Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium. Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium  Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium
Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium
For Condition: Bladder Cancer,Urethral Cancer,transitional cell cancer of the renal pelvis and ureter
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced transitional cell carcinoma of the urothelium.
Details: OBJECTIVES: Primary - Determine the efficacy of bortezomib, in terms of the response rate, in patients with previously treated advanced transitional cell carcinoma of the urothelium. Secondary - Determine the duration of objective response in patients treated with this drug. - Determine the progression-free and overall survival of patients treated with this drug. - Determine the safety and toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with a solitary site of disease (i.e., lung or nodal metastases) and who have a partial response (PR) may be considered for surgical resection. Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy. Patients who achieve a complete response, either through resection or bortezomib therapy, receive 2 additional courses of study therapy. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 13-17 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis - Previously treated with 1 prior systemic chemotherapy* for advanced or metastatic disease - Progressive disease during or after chemotherapy regimen - Must have included at least 1 of the following agents: - Cisplatin - Carboplatin - Paclitaxel - Gemcitabine NOTE: *Neoadjuvant and adjuvant combination chemotherapy is considered a systemic chemotherapy, while radiosensitizing single-agent chemotherapy is not - Unidimensionally measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Nonmeasurable disease includes the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Primary bladder masses - No known active brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 8 g/dL Hepatic - Bilirubin less than 1.8 g/dL - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 2.5 mg/dL OR - Creatinine clearance greater than 30 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study treatment - Standard chemistry panel normal - No peripheral neuropathy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy - No concurrent hormonal therapy except for the following: - Steroids for adrenal failure - Hormones for non-disease-related conditions (e.g., insulin for diabetes) - Intermittent dexamethasone as an antiemetic Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - No concurrent palliative radiotherapy Surgery - Not specified Other - No prior bortezomib or other proteasome inhibitors - No prior investigational agents as a single-agent therapy - Prior investigational agents incorporated into prior systemic chemotherapy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanRosenberg, Study Chair, University of California, San Francisco
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Hyman Muss 802-847-3827
Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting William Patterson 573-882-6163
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Debasish Tripathy 214-648-5113
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Canellos 617-632-3470
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Lewis Silverman 212-241-5520
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Clara Bloomfield 614-293-7518
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Pankaj Bhargava 508-856-6884
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Thomas Shea 919-966-7746
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Gerald Clamon 319-356-1932
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Barnes-Jewish Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-747-3000
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Alan Venook 800-888-8664
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Joseph Drabick 202-782-6751
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-476-7461
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Alan Lefor 310-423-5874
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-464-8200
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Stephen Seagren 858-657-7020
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Richard Shadduck 412-578-4355
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Clifford Hudis 212-639-6483
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8915
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8958
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jeffrey Crawford 919-684-5195
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Vicki Morrison 612-725-2000 ext. 4135
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bruce Peterson 612-624-5631
Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Joseph O'Donnell 802-295-9363 ext. 5480
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Rogerio Lilenbaum 305-674-2625
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Patricia Cornett 415-221-4810 ext. 3423
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
Veterans Affairs Medical Center - Durham *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
Lifespan: The Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting William Sikov 401-793-7151
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Edward Gelmann 202-444-7303
Missouri Baptist Cancer Center *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Alan Lyss 314-996-5514
Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Lynn Steinbrenner 716-862-3191
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Marc Ernstoff 603-650-5534
Additional Information:
Study ID Numbers: CDR0000335517; CALGB-90207
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072150
Other Urethral Cancer Studies:
1. Bladder Cancer Case Control Study of Arsenic in Water
2. Combination Chemotherapy Followed By Observation or Surgery in Treating Patients With Stage II or Stage III Cancer of the Urothelium
3. Short-Term Low-Dose Interferon alfa in Treating Patients With Cancer of the Urothelium
4. BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer
5. Decitabine in Treating Patients With Advanced Solid Tumors
Related Studies:
Other Urethral Cancer Clinical Trials
Other Florida Clinical Trials
Other Orlando Clinical Trials
Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium
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