Status:
COMPLETED
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine ...
Detailed Description
OBJECTIVES: * Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete response rate, in patients with recurrent superficial transitional cell carcinoma of the bladder that ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed superficial transitional cell carcinoma (TCC) of the bladder meeting 1 of the following stage criteria:
- Stage T1, grade 2-3
- Stage Tis
- Stage Ta, grade 3-4 or multifocal (\> 2 lesions)
- Must have received and failed ≥ 2 courses of intravesical Bacillus Calmette-Guerin (BCG) (one 6-week course, plus one 3-week course, or fewer weeks if BCG was discontinued due to side effects) within the past 3 years
- Recurrent disease
- Must have had a transurethral resection of the bladder tumor (TURBT) or bladder biopsy within the past 60 days documenting tumor recurrence and tumor stage and grade
- TURBT or biopsy must have been performed ≥ 6 weeks after the completion of BCG and/or other immunotherapy treatment (or ≥ 14 days after completion of intravesical chemotherapy treatment)
- All visible tumor must have been resected at the time of the last biopsy
- No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- 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 in complete remission
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Prior intravesical interferon alfa allowed, alone or in combination with Bacillus Calmette-Guerin (BCG)
- Chemotherapy
- See Disease Characteristics
- No more than 1 course of intravesical chemotherapy (e.g., thiotepa, mitomycin, or doxorubicin) within the past year, defined as 6 or more weekly instillations, with or without monthly maintenance instillations
- No prior gemcitabine
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior pelvic radiotherapy
- No concurrent radiotherapy to any other area of the body
- Surgery
- See Disease Characteristics
- Recovered from prior surgery
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00234039
Start Date
November 1 2006
End Date
April 1 2013
Last Update
January 8 2016
Active Locations (98)
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1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
Cancer Centers of Central Florida, PA
Leesburg, Florida, United States, 34788
4
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813