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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | November 1996 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002919 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer | ||||
| Official Title ICMJE | PHASE II TRIAL OF THE COMBINATION OF TRANSURETHRAL RESECTION AND NEOADJUVANT CHEMOTHERAPY FOR PATIENTS WITH INVASIVE UROTHELIAL TRACT TUMORS SELECTED BY STAGE AND P53 NUCLEAR EXPRESSION | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Bladder Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 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 PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy No prior bladder irradiation |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002919 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065305, MSKCC-96066, NCI-H97-1118 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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