Back to resultsCombination Chemotherapy in Treating Patients With Stage II Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
cisplatin
doxorubicin hydrochloride
methotrexate
vinblastine sulfate
conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage II bladder cancer, transitional cell carcinoma of the bladder
Eligibility 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 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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002919
First Posted
November 1, 1999
Last Updated
July 1, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00002919
Brief Title
Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage II bladder cancer, transitional cell carcinoma of the bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean F. Bajorin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
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