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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

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ClinicalTrials.gov Identifier: NCT00080795
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : October 22, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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





Primary Outcome Measures :
  1. Response rate [ Time Frame: 6 weeks following treatment ]
  2. Disease-free survival at 4 years [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Comparison of perioperative treatment morbidity and mortality with historical standards [ Time Frame: Minimally reviewed following 6 weeks post treatment ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Randall E. Millikan, MD, PhD M.D. Anderson Cancer Center
Study Chair: Colin P. Dinney, MD M.D. Anderson Cancer Center

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00080795     History of Changes
Other Study ID Numbers: CDR0000355361
MDA-ID-01317
ID01-317 ( Other Identifier: UT MD Anderson Cancer Center )
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012
Keywords provided by M.D. Anderson Cancer Center:
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
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Gemcitabine
Cisplatin
Doxorubicin
Liposomal doxorubicin
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors