A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
N/A
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
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 Clinic | New Orleans, Louisiana 70112 |
