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


Phase 2
N/A
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

6 weeks following treatment

Safety Issue:

No

Principal Investigator

Randall E. Millikan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000355361

NCT ID:

NCT00080795

Start Date:

July 2001

Completion Date:

May 2006

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030