Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT00087295
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00087295
Study Brief:
Protocol Section:
NCT00087295