Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer
18 Years
N/A
Both
Bladder Cancer
Trial Information
Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer
OBJECTIVES:
Primary
- Determine response in patients with locally advanced or metastatic transitional cell
carcinoma of the bladder treated with gemcitabine and irinotecan.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this
regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes
on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond
best response.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell carcinoma of the bladder
- Locally advanced or metastatic disease
- Unidimensionally measurable disease by physical exam or imaging study
- The following are not considered measurable disease:
- Bone only disease
- Pleural or peritoneal effusions
- CNS lesions
- Irradiated lesions unless disease progression was documented after
radiotherapy
- Not amenable to surgery
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine ≤ 2.0 mg/dL
Gastrointestinal
- No active inflammatory bowel disease
- No significant bowel obstruction
- No chronic diarrhea
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy except nonmelanoma skin cancer
- No mental incapacitation or psychiatric illness that would preclude giving informed
consent
- No other severe disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- No more than 1 prior platinum-based chemotherapy regimen
- At least 4 weeks since prior chemotherapy
- No prior irinotecan or gemcitabine
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormones except steroids for adrenal failure, hormones for
non-disease-related conditions (e.g., insulin for diabetes), and intermittent
dexamethasone as an antiemetic
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent palliative radiotherapy
Surgery
- Not specified
Other
- No concurrent participation in another clinical trial
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Safety Issue:
No
Principal Investigator
Uzair B. Chaudhary, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medical University of South Carolina
Authority:
United States: Federal Government
Study ID:
CDR0000378047
NCT ID:
NCT00089128
Start Date:
November 2001
Completion Date:
October 2010
Related Keywords:
- Bladder Cancer
- transitional cell carcinoma of the bladder
- recurrent bladder cancer
- stage III bladder cancer
- stage IV bladder cancer
- Urinary Bladder Neoplasms
Name | Location |
|---|---|
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
