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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002919 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: methotrexate Drug: vinblastine Procedure: conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 1996 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Dean F. Bajorin, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000065305, MSKCC-96066, NCI-H97-1118 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002919 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II bladder cancer transitional cell carcinoma of the bladder |
|
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Folate Vinblastine Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Vitamin B9 Anti-Bacterial Agents Urologic Diseases Cisplatin Methotrexate Bladder Neoplasm |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Antimitotic Agents Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Doxorubicin Carcinoma Folic Acid Tubulin Modulators Antirheumatic Agents Antineoplastic Agents, Phytogenic Transitional Cell Carcinoma |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Urogenital Neoplasms Reproductive Control Agents Antibiotics, Antineoplastic Urologic Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Abortifacient Agents |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Tubulin Modulators |
