Status:
TERMINATED
S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying ...
Detailed Description
OBJECTIVES: * Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00087295
Start Date
June 1 2004
End Date
April 1 2006
Last Update
November 2 2012
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