A Research Study for Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00106418
First received: March 24, 2005
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Metastases
Drug: romidepsin (depsipeptide, FK228)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Estimated Enrollment: 25
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00106418     History of Changes
Obsolete Identifiers: NCT00058643
Other Study ID Numbers: FJ-228-0002
Study First Received: March 24, 2005
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Prostate Cancer
Androgen independent metastatic prostate cancer patients with rising PSA
romidepsin

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Romidepsin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014