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Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium Clinical research trials and Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium. Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium clinical trial. Test subjects typically receive the most expert healthcare available for their Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium  Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
For Condition: anterior urethral cancer,posterior urethral cancer,metastatic transitional cell cancer of the renal pelvis and ureter,urethral cancer associated with invasive bladder cancer,regional transitional cell cancer of the renal pelvis and ureter,stage 3 bladder cancer,stage 4 bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating advanced cancer of the urothelium. PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination chemotherapy with that of two-drug combination chemotherapy in treating patients who have advanced cancer of the urothelium.
Details: OBJECTIVES: I. Compare the objective response rate, duration of remission, overall survival, and quality of life of patients with progressing regional or metastatic transitional cell carcinoma (or mixed histologies with a component of transitional cell carcinoma) of the urothelium treated with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) compared to carboplatin and paclitaxel. II. Compare the relative toxicities of M-VAC versus those encountered with carboplatin and paclitaxel in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive either methotrexate, vinblastine, doxorubicin, and cisplatin (arm I) or paclitaxel and carboplatin (arm II). Arm I: Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days 2, 15, and 22, and cisplatin IV over 2 hours and doxorubicin IV on day 2. Courses repeat every 28 days. Arm II: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes. Courses repeat every 21 days. Each treatment arm continues for a maximum of 6 courses in the absence of unacceptable toxic effects or disease progression. Quality of life is assessed before treatment, before courses 2 and 4, at 4 weeks after last course, and at 10 months. Patients are followed every 3 months for 1 year, and then every 6 months until disease progression. PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study within 3.3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed transitional cell carcinoma of the urothelium (renal pelvis, ureter, bladder, urethra) or mixed histologies containing a component of transitional cell carcinoma of the urothelium with manifestations of progressing regional or metastatic cancer - Clinically unsuspected organ confined prostate cancer found during cystoprostatectomy allowed - Evaluable or measurable disease - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior systemic biologic response modifier therapy - Chemotherapy: No prior systemic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior pelvic radiotherapy as a component of bladder sparing therapy or as an adjuvant for locally advanced disease with positive margins - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: AST no greater than 2 times upper limit of normal; Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.7 mg/dL - Cardiovascular: No history of severe cardiovascular disease (American Heart Association class III or IV), uncontrolled congestive heart failure, or cardiac dysrhythmias; No significant pericardial effusion or edema - Pulmonary: No significant pleural effusion or edema - Other: No significant ascites; Prior malignancy allowed if curatively treated with no evidence of recurrence; No active infection requiring antibiotics; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertComis, Study Chair, Eastern Cooperative Oncology Group
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000066368; E-4897,GUMC-01011
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003376
Other Urethral Cancer Associated With Invasive Bladder Cancer Studies:
1. Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
2. Trastuzumab in Treating Patients With Previously Treated, Locally Advanced or Metastatic Kidney Cancer
3. Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer
4. Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
5. Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
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Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
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