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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080795 |
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: ifosfamide Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer |
Estimated Enrollment: | 49 |
Study Start Date: | July 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy.
Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Randall E. Millikan, MD, PhD | M.D. Anderson Cancer Center |
Investigator: | Colin P. Dinney, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000355361, MDA-ID-01317 |
Study First Received: | April 7, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00080795 History of Changes |
Health Authority: | United States: Federal Government |
stage III bladder cancer regional transitional cell cancer of the renal pelvis and ureter anterior urethral cancer posterior urethral cancer urethral cancer associated with invasive bladder cancer |
Antimetabolites Anti-Infective Agents Urinary Tract Neoplasm Immunologic Factors Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Anti-Bacterial Agents Renal Cancer Urologic Diseases Cisplatin Kidney Neoplasms Urethral Cancer Kidney Diseases |
Bladder Neoplasm Gemcitabine Alkylating Agents Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Immunosuppressive Agents Antiviral Agents Doxorubicin Carcinoma Ifosfamide Radiation-Sensitizing Agents Mechlorethamine Urethral Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Antibiotics, Antineoplastic Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Cisplatin |
Kidney Neoplasms Therapeutic Uses Urethral Diseases Kidney Diseases Gemcitabine Alkylating Agents Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Doxorubicin Pharmacologic Actions Carcinoma |