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A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium


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

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Trial Information

A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium


OBJECTIVES:

- Determine the time to treatment failure and disease-free survival in patients with
high-risk transitional cell carcinoma of the urothelium treated with adjuvant
paclitaxel, ifosfamide, carboplatin, and gemcitabine.

- Determine the tolerability and feasibility of this regimen in these patients.

OUTLINE: Patients are stratified according to disease stage.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1,
ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily
beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21
days for a total of 2 courses.

Beginning 3 weeks after the completion of the second course of chemotherapy, patients
receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day
1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and
continuing until blood counts recover. Treatment repeats every 21 days for a total of 2
courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3
years.

PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter,
and renal pelvis

- T3b-4, N0, M0 OR

- Any T, N1-3, M0

- Cystectomy within the past 8 weeks

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- ECOG 0-1

Life expectancy:

- At least 12 months

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST or ALT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than ULN

- Albumin no greater than ULN

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior malignancy except curatively treated carcinoma in situ of the cervix
or non-melanoma skin cancer

- No active serious infection, other serious underlying medical condition, dementia, or
significantly altered mental status that would preclude study participation

- No known hypersensitivity to Cremophor EL

- No pre-existing clinically significant grade 2 or greater neuropathy

- No AIDS (HIV positivity alone allowed)

- No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for malignancy

- No neoadjuvant chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for malignancy

Surgery:

- See Disease Characteristics

Other:

- No other concurrent investigational therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Raja Mudad, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Tulane University Health Sciences Center

Authority:

United States: Federal Government

Study ID:

TULCC-RM-002

NCT ID:

NCT00028860

Start Date:

October 2001

Completion Date:

October 2004

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • stage III bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • localized transitional cell cancer of the renal pelvis and ureter
  • regional transitional cell cancer of the renal pelvis and ureter
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urologic Neoplasms

Name

Location

Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112