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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00478361 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
PURPOSE: This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Neutropenia Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Biological: pegfilgrastim Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency |
| Estimated Enrollment: | 72 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride IV over 20 minutes, paclitaxel IV over 60 minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder, urethra, or upper urinary tract
Measurable disease
Creatinine clearance < 60 mL/min
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy
Contacts and Locations
Show 28 Study Locations| Study Chair: | Lance C. Pagliaro, MD | M.D. Anderson Cancer Center |
| Investigator: | Arlene Siefker-Radtke, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( Lance C. Pagliaro ) |
| Study ID Numbers: | CDR0000544831, MDA-2005-0839, MDA-2005-0939 |
| Study First Received: | May 23, 2007 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00478361 History of Changes |
| Health Authority: | United States: Federal Government |
|
neutropenia metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter urethral cancer associated with invasive bladder cancer anterior urethral cancer posterior urethral cancer |
recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer regional transitional cell cancer of the renal pelvis and ureter stage III bladder cancer |
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Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Leukocyte Disorders Antibiotics, Antineoplastic Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases |
Kidney Neoplasms Therapeutic Uses Urethral Diseases Kidney Diseases Gemcitabine Neoplasms by Histologic Type Hematologic Diseases Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Agranulocytosis Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Antiviral Agents |