Status:
COMPLETED
A Research Study for Patients With Prostate Cancer
Lead Sponsor:
Celgene
Conditions:
Prostate Cancer
Metastases
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00106418
Start Date
May 7 2003
End Date
September 1 2006
Last Update
November 18 2019
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