Tipifarnib in Treating Patients With Recurrent Bladder Cancer (NCT00047216) | Clinical Trial Compass
CompletedPhase 2
Tipifarnib in Treating Patients With Recurrent Bladder Cancer
United States, CanadaStarted 2002-11
Plain-language summary
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma (TCC) of the bladder with or without associated carcinoma in situ
* Stage 0 or I (Ta or T1)
* Grade 1, 2, or 3 TCC
* Cystoscopically and histologically confirmed recurrent disease after at least 1 course of standard first-line intravesical therapy (e.g., BCG or mitomycin) within the past 12 months
* Complete transurethral resection of bladder tumor performed within past 4 weeks
* Rendered clinically and cystoscopically tumor free
* Negative cytology
* No upper tract TCC by intravenous pyelogram, retrograde pyelogram, or CT scan of kidneys (with contrast)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* More than 1 year
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal (ULN)
Renal
* Creatinine no greater than 1.25 times ULN OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No uncontrolled hypertension
Other
* Able to swallow and retain oral medication
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reactions to compounds of similar chemical or biological compositio…