S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelium (bladder, renal pelvis, ureter, or urethra) Metastatic disease Node-positive, non-metastatic disease that is unresectable is allowed Poorly differentiated transitional cell carcinoma OR predominant transitional cell carcinoma with rare foci of squamous differentiation or rare foci of adenocarcinoma allowed The following histologic types are not allowed: Adenocarcinoma Small cell carcinoma Sarcoma Squamous cell carcinoma Mixed adeno/squamous/transitional histology Measurable disease At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan Soft tissue disease irradiated within the past 2 months is not considered measurable Disease progression or recurrence after 1, and only 1, prior systemic chemotherapy regimen that included cisplatin or carboplatin for metastatic disease Not curable by surgery or radiotherapy No known brain metastases PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 White blood cell (WBC) count ≥ 3,000/mm^3 Hepatic Aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) ≤ 2.5 times upper limit of normal (ULN) Bilirubin normal Renal Creatinine ≤ 2 times ULN Cardiovascular Corrected QT interval (QTc) < 500 msec Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA) No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past year No uncontrolled dysrhythmias No poorly controlled angina No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) No left ventricular hypertrophy on EKG No other significant cardiac disease Other Potassium ≥ 4 mmol/L Magnesium ≥ 2 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No prior allergic reaction to compounds of similar chemical or biological composition to FR901228 (depsipeptide) 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 in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 28 days since prior chemotherapy No prior FR901228 (depsipeptide) No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Radiotherapy See Disease Characteristics More than 28 days since prior radiotherapy No concurrent radiotherapy Surgery More than 28 days since prior surgery Other Recovered from all prior therapy More than 28 days since prior intravesical therapy No concurrent hydrochlorothiazide No concurrent agent that causes QTc prolongation No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational histone deacetylase inhibitor agents or drugs (e.g., sodium valproate) No other concurrent anticancer therapy
Sites / Locations
Arms of the Study
Arm 1
Experimental
Treatment
Depsipeptide