A Research Study for Patients With Prostate Cancer

November 14, 2019 updated by: Celgene

An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Androgen Independent Metastatic Prostate Cancer Patients With Rising PSA

The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males ≥18 years;
  • Written informed consent/authorization;
  • Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy (objective progressive disease [PD], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
  • Patients must have either measurable disease or bone metastasis. Patients with measurable disease are preferred;
  • Rising PSA, with a minimum study entry PSA of ≥5 ng/mL;
  • Karnofsky performance status of ≥80%;
  • Life expectancy of >12 weeks;
  • For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
  • Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment);
  • Serum testosterone level of <50 ng/mL in patients without surgical castration;
  • Patients must have serum potassium levels >4.0 mEq/L and serum magnesium levels >2.0 mg/dL.

Exclusion Criteria:

  • Concomitant use of any anti-cancer therapy, except for continued use of luteinizing hormone-releasing hormone (LHRH) agonists or antiandrogens, or bisphosphonates or steroids initiated at least 4 weeks prior to study entry;
  • Concomitant use of any investigational agent, including PC-SPES;
  • Use of any investigational agent within 4 weeks of study entry;
  • Concomitant use of warfarin (due to a potential drug-to-drug interaction with depsipeptide);
  • Major surgery within 2 weeks of study entry;
  • Prior treatment with chemotherapy;
  • Patients with known cardiac abnormalities such as:
  • Congenital long QT syndrome;
  • QTc interval > 480 milliseconds;
  • Patients who have had a myocardial infarction within 12 months of study entry;
  • Patients who have a history of coronary artery disease (CAD) e.g., angina Canadian Class II IV (see Appendix K). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
  • Patients with an ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
  • Patients with congestive heart failure that meets NYHA Class II to IV (see Appendix J) definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI);
  • Patients with a history of sustained VT, VF, Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
  • Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above);
  • Patients with uncontrolled hypertension i.e., ≥160/95;
  • Patients with any cardiac arrhythmia requiring anti-arrhythmic medication;
  • Concomitant use of medications which may cause a prolongation of QT/QTc (see Appendix D) interval;
  • Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 (see Appendix E);
  • Clinically significant active infection;
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
  • Previous extensive radiotherapy involving 30% of bone marrow (e.g., whole of pelvis, half of spine);
  • Clinical or radiological imaging evidence of brain metastasis (computed tomography [CT] or MRI scans are required only if brain metastasis is suspected clinically);

  • Inadequate bone marrow or other organ function, as evidenced by:

    • hemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);
    • absolute neutrophil count (ANC) ≤1.5 x 109 cells/L;
    • platelet count <100 x 109 cells/L;
    • total bilirubin >1.25 x upper limit of normal (ULN) for institution or >2.0 x ULN in the presence of demonstrable liver metastases;
    • aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN or >5.0 x ULN in the presence of demonstrable liver metastases;
    • serum creatinine >2 mg/dL;
  • Serum potassium levels < 4.0 mEq/L and serum magnesium levels <2.0 mg/dL;
  • Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively); or
  • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Romidepsin
13 mg/m^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Drug: Romidepsin
13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
  • Istodax
  • depsipeptide
  • FK 228

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of objective disease control
Time Frame: Up to 6 months
Rate of objective disease control was defined as the proportion of patients with confirmed CR, PR, or SD for at least 6 months, as determined by the Response Evaluation Criteria for Solid Tumors (RECIST).
Up to 6 months

Collaborators and Investigators

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

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 7, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

March 24, 2005

First Submitted That Met QC Criteria

March 24, 2005

First Posted (Estimate)

March 25, 2005

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJ-228-0002

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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