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

NCT00087295 | Terminated Phase 2

• 3 other identifiers: CDR0000373886U10CA032102S0400
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Probability of response (confirmed complete and partial)

  From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes (3)

• Progression-free survival

  From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

• Overall survival

  From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

• Number and grade of adverse events

  From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Study Arms (1)

Treatment

EXPERIMENTAL

Depsipeptide

Drug: Depsipeptide

Interventions

Depsipeptide DRUG

Depsipeptide wil be given 13 mg/m\^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.

Also known as: FR901228, FK228

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Depsipeptides; romidepsin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Daniel P. Petrylak, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: June 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: November 2, 2012

Record last verified: 2012-10