Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310011 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium |
Estimated Enrollment: | 71 |
Study Start Date: | June 1998 |
OBJECTIVES:
OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy (yes vs no).
Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a partial response or complete response undergo surgical restaging and debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements
Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Carolinas Hematology-Oncology Associates | |
Charlotte, North Carolina, United States, 28203-4239 | |
Regional Cancer Center | |
Greensboro, North Carolina, United States, 27403-1199 | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Study Chair: | Frank M. Torti, MD, MPH | Wake Forest University |
Study ID Numbers: | CDR0000466059, CCCWFU-88197, CCCWFU-BG98-217, AMGEN-CCCWFU-88197 |
Study First Received: | March 29, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00310011 History of Changes |
Health Authority: | United States: Federal Government |
metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter transitional cell carcinoma of the bladder |
regional transitional cell cancer of the renal pelvis and ureter stage IV bladder cancer recurrent bladder cancer |
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Renal Cancer Urologic Diseases Cisplatin Kidney Neoplasms Kidney Diseases Bladder Neoplasm Gemcitabine Kidney Cancer |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Antimitotic Agents Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic Ureteral Neoplasms Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Cisplatin Kidney Neoplasms |
Therapeutic Uses Kidney Diseases Gemcitabine Neoplasms by Histologic Type Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents |