Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
18 Years
N/A
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Trial Information
Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
OBJECTIVES:
- Determine the probability of response (confirmed complete and partial response) to
treatment with irinotecan in patients with recurrent or refractory advanced
transitional cell carcinoma of the urothelium previously treated with platinum-based
chemotherapy.
- Determine the qualitative and quantitative toxic effects of this drug in these
patients.
- Determine the overall and progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic
radiotherapy (yes vs no).
Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell carcinoma (TCC) of the urothelium,
including the bladder, renal pelvis, ureter, and urethra
- Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease
- The following additional histologic subtypes are eligible:
- Poorly differentiated TCC
- Predominant TCC with rare foci of squamous differentiation
- Predominant TCC with rare foci of adenocarcinoma
- The following histologic subtypes are ineligible:
- Adenocarcinoma
- Small cell carcinoma
- Sarcoma
- Squamous cell carcinoma
- Mixed adeno/squamous/transitional histology
- Incurable by surgery or radiotherapy
- Progressed or recurred after 1, and only 1, prior cisplatin- or
carboplatin-containing systemic regimen for metastatic disease
- Measurable disease
- Soft tissue disease that has been irradiated within the past 2 months is not
considered measurable disease
- No uncontrolled central nervous system (CNS) metastases
- CNS metastases that have responded to or stabilized after prior radiotherapy are
allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,200/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (SGOT) less than 3 times ULN (5 times ULN if liver
metastases are present)
Renal
- Creatinine less than 2 times ULN
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 28 days since prior chemotherapy
- No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan)
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy to the pelvis
Surgery
- Not specified
Other
- Recovered from prior therapy
- Prior adjuvant therapy allowed
- At least 14 days since prior Hypericum perforatum (St. John's Wort)
- More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other
enzyme-inducing anticonvulsant drugs (EIACDs)
- No St. John's Wort during and for 7 days after study participation
- No concurrent EIACDs
- No concurrent medications that cause myelosuppression
- No concurrent medications that cause diarrhea
- Concurrent gabapentin or other non-EIACDs are allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Probability of response (confirmed complete and partial response)
Outcome Time Frame:
From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Safety Issue:
No
Principal Investigator
Tomasz M. Beer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000316428
NCT ID:
NCT00066612
Start Date:
July 2003
Completion Date:
May 2010
Related Keywords:
- Bladder Cancer
- Transitional Cell Cancer of the Renal Pelvis and Ureter
- Urethral Cancer
- recurrent bladder cancer
- stage IV bladder cancer
- metastatic transitional cell cancer of the renal pelvis and ureter
- recurrent transitional cell cancer of the renal pelvis and ureter
- regional transitional cell cancer of the renal pelvis and ureter
- transitional cell carcinoma of the bladder
- anterior urethral cancer
- posterior urethral cancer
- recurrent urethral cancer
- urethral cancer associated with invasive bladder cancer
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Urethral Neoplasms
- Kidney Neoplasms
- Ureteral Neoplasms
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