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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Depsipeptide
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Depsipeptide

    Outcomes

    Primary Outcome Measures

    Probability of response (confirmed complete and partial)

    Secondary Outcome Measures

    Progression-free survival
    Overall survival
    Number and grade of adverse events

    Full Information

    First Posted
    July 8, 2004
    Last Updated
    October 31, 2012
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00087295
    Brief Title
    S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
    Official Title
    A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Terminated
    Why Stopped
    Permanently Closed Due to Poor Accrual
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    April 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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 with FR901228 (depsipeptide) . Determine progression-free and overall survival of patients treated with this drug. Determine the qualitative and quantitative toxic effects of this drug in these patients. Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients. Correlate, preliminarily, tumor DNA in plasma with response or outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response receive 2 additional courses of treatment. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Depsipeptide
    Intervention Type
    Drug
    Intervention Name(s)
    Depsipeptide
    Other Intervention Name(s)
    FR901228, FK228
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Probability of response (confirmed complete and partial)
    Time Frame
    From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Time Frame
    From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
    Title
    Overall survival
    Time Frame
    From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
    Title
    Number and grade of adverse events
    Time Frame
    From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel P. Petrylak, MD
    Organizational Affiliation
    Herbert Irving Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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