S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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 how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Romidepsin

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