Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
NCT ID: NCT00080795
Last Updated: 2012-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2001-07-31
2006-05-31
Brief Summary
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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.
Detailed Description
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Primary
* 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.
Secondary
* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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filgrastim
cisplatin
doxorubicin hydrochloride
gemcitabine hydrochloride
ifosfamide
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease:
* Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia
* Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum
* Lymphovascular invasion on transurethral resection specimen
* Upper tract disease or micropapillary histology allowed
* No evidence of disease outside the pelvis
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* 0-2
Life expectancy
* Not specified
Hematopoietic
* Bone marrow function adequate
Hepatic
* Liver function adequate
Renal
* Creatinine clearance ≥ 45 mL/min
Cardiovascular
* Ejection fraction ≥ 50%
Other
* Not pregnant
* No other malignancy likely to be life-threatening within the next 4 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Randall E. Millikan, MD, PhD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Colin P. Dinney, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Other Identifiers
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MDA-ID-01317
Identifier Type: -
Identifier Source: secondary_id
ID01-317
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000355361
Identifier Type: -
Identifier Source: org_study_id