Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
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|ClinicalTrials.gov Identifier: NCT00080795|
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : October 22, 2012
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 or disease||Intervention/treatment||Phase|
|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 2|
- Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide.
- Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- Response rate [ Time Frame: 6 weeks following treatment ]
- Disease-free survival at 4 years [ Time Frame: 4 years ]
- Comparison of perioperative treatment morbidity and mortality with historical standards [ Time Frame: Minimally reviewed following 6 weeks post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080795
|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|
|Study Chair:||Colin P. Dinney, MD||M.D. Anderson Cancer Center|