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

October 31, 2012 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Depsipeptide
Drug: Depsipeptide
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.
Other Names:
  • FK228
  • FR901228

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Overall survival
Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
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
Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

July 8, 2004

First Submitted That Met QC Criteria

July 9, 2004

First Posted (Estimate)

July 12, 2004

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000373886
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0400 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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