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Sponsored by: |
Tulane University Health Sciences Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028860 |
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 who have urinary tract cancer.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter |
Drug: carboplatin Drug: filgrastim Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: paclitaxel Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease stage.
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses.
Beginning 3 weeks after the completion of the second course of chemotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Louisiana | |
Tulane Cancer Center at Tulane University Hospital and Clinic | |
New Orleans, Louisiana, United States, 70112 |
Study Chair: | Raja Mudad, MD, FACP | Tulane University Health Sciences Center |
Study ID Numbers: | CDR0000069142, TULCC-RM-002, AMGEN-TULCC-RM-002, BMS-TULCC-RM-002 |
Study First Received: | January 4, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00028860 |
Health Authority: | United States: Federal Government |
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder localized transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carboplatin Renal cancer Kidney cancer Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma Carcinoma |
Ifosfamide Urologic Diseases Paclitaxel Kidney Neoplasms Kidney Diseases Gemcitabine Ureteral Neoplasms Urinary tract neoplasm Isophosphamide mustard Bladder neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents |