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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003376 |
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.
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Drug: methotrexate Drug: paclitaxel Drug: vinblastine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Trial of Methotrexate, Vinblastine, Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced Carcinoma of the Urothelium |
Estimated Enrollment: | 330 |
Study Start Date: | September 1998 |
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 vs carboplatin and paclitaxel. II. Compare the relative toxic effects of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. 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. Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression. Arm II: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for a total of 6 courses in the absence of unacceptable toxicity 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelium (renal pelvis, ureter, bladder, or 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 significant pericardial or pleural effusion or edema No significant ascites No CNS metastases
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 Other: Prior malignancy allowed if curatively treated with no evidence of recurrence No active infection requiring parenteral antibiotics Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy No concurrent filgrastim (G-CSF) within 24 hours prior to and after study chemotherapy administration 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 No concurrent local radiotherapy for pain control or life-threatening situations Surgery: See Disease Characteristics
Study Chair: | Bruce J. Roth, MD | Vanderbilt-Ingram Cancer Center |
Study Chair: | Martin J. Edelman, MD | Veterans Affairs Medical Center - Baltimore |
Study ID Numbers: | CDR0000066368, E-4897, CLB-99908, GUMC-01011 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003376 History of Changes |
Health Authority: | United States: Federal Government |
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder anterior urethral cancer |
posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Folate Ureteral Diseases Urogenital Neoplasms Vinblastine Urologic Neoplasms Carcinoma, Transitional Cell Vitamin B9 Anti-Bacterial Agents Renal Cancer Cisplatin Urologic Diseases Kidney Neoplasms |
Urethral Cancer Methotrexate Kidney Diseases Bladder Neoplasm Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Antimitotic Agents Carboplatin Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Doxorubicin Carcinoma |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Vinblastine Reproductive Control Agents Antibiotics, Antineoplastic Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases |
Cisplatin Kidney Neoplasms Therapeutic Uses Abortifacient Agents Urethral Diseases Methotrexate Kidney Diseases Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents |