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Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium

Primary Purpose

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
cisplatin
doxorubicin hydrochloride
gemcitabine hydrochloride
ifosfamide
conventional surgery
neoadjuvant therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, regional transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • M.D. Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Response rate
Disease-free survival at 4 years

Secondary Outcome Measures

Comparison of perioperative treatment morbidity and mortality with historical standards

Full Information

First Posted
April 7, 2004
Last Updated
October 18, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00080795
Brief Title
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
Official Title
Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Keywords
stage III bladder cancer, regional transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Response rate
Time Frame
6 weeks following treatment
Title
Disease-free survival at 4 years
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Comparison of perioperative treatment morbidity and mortality with historical standards
Time Frame
Minimally reviewed following 6 weeks post treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall E. Millikan, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Colin P. Dinney, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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