Status:
TERMINATED
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Lead Sponsor:
Medical University of South Carolina
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill m...
Detailed Description
OBJECTIVES: Primary * Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan. Secondary * Determine t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00089128
Start Date
November 1 2001
End Date
November 1 2008
Last Update
July 12 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425