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Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer. Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer  Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
For Condition: stage 2 bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with stage II bladder cancer.
Details: OBJECTIVES: I. Determine the efficacy of combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) following aggressive transurethral resection of bladder tumors in patients with stage II transitional cell carcinoma of the bladder without nuclear overexpression of mutant p53. II. Determine the proportion of patients treated with this regimen in whom bladder preservation rather than radical cystectomy is possible. PROTOCOL OUTLINE: All patients undergo complete or near complete transurethral resection of the bladder tumor at entry or within 6 weeks prior to entry. Upon confirmation of staging and histology, patients receive combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) every 21 days for 4 courses. Subcutaneous G-CSF is given with each course. Patients with a complete response after chemotherapy proceed to intravesical therapy or observation; those with a partial response, stable disease, or progression proceed to definitive surgery. PROJECTED ACCRUAL: 30 patients will be entered over approximately 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Invasive transitional cell carcinoma of the bladder that is clinical stage; T2-3a; N0; M0 by cystoscopy; Cystoscopy performed at Memorial Sloan-Kettering Cancer Center (MSKCC); No multifocal carcinoma in situ; No obstructive uropathy or palpable mass - Pathologic confirmation of histology and no more than 20% positive expression of nuclear p53, as follows: On study following transurethral resection of the bladder (TURB) OR At TURB performed within 6 weeks of entry as part of initial staging --Prior/Concurrent Therapy-- - No prior systemic chemotherapy; No prior bladder irradiation --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60%-100% - Hematopoietic: WBC at least 3,500; Platelets greater than 150,000 - Hepatic: Bilirubin less than 2.0 mg/dL - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min per 1.73 square meters - Cardiovascular: No NYHA class III/IV status - Other: No concomitant malignancy other than basal cell skin carcinoma; Negative pregnancy test required of fertile women; Adequate contraception required of fertile women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeanBajorin, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000065305; MSKCC-96066,NCI-H97-1118
Study Start Date: November 1996
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002919
Other Stage 2 Bladder Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Bladder Cancer
2. R115777 in Treating Patients With Advanced Bladder Cancer
3. Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
4. Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer
5. Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
Related Studies:
Other stage 2 bladder cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
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