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Completed

NCT Number: NCT00080795

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Cisplatin

Drug

Doxorubicin hydrochloride

Drug

gemcitabine hydrochloride

Drug

ifosfamide

Drug

conventional surgery

Procedure

neoadjuvant therapy

Procedure

Primary outcomes

  1. Response rate

    Time frame: 6 weeks following treatment

  2. Disease-free survival at 4 years

    Time frame: 4 years

Secondary outcomes

  1. Comparison of perioperative treatment morbidity and mortality with historical standards

    Time frame: Minimally reviewed following 6 weeks post treatment

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Apr 8, 2004
Registry last updated
Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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