Phase 2
Completed N=36
Vidaza to Restore Hormone Thx Prostate
Source: ClinicalTrials.gov NCT00384839 ↗Enrolled (actual)
36
Serious AEs
2.9%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Patients With PSA Doubling Time >=3 Months. — 55.8 % of patients with PSA-DT>= 3 months
Summary
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With PSA Doubling Time >=3 Months. |
55.8 | — |
| SECONDARY PSA Response Rate |
— | — |
| SECONDARY Objective Response Rate by Recist (ORR) |
— | — |
| SECONDARY Progression-free Survival |
12.4 | — |
| SECONDARY 1-year Overall Survival (OS) |
0.73 | — |
| SECONDARY Changes in Fetal Hemoglobin (HbF) With Time. |
12.7 | — |
Eligibility Criteria
INCLUSION CRITERIA
- A diagnosis of histologically confirmed, progressive, advanced metastatic, or nonmetastatic prostate cancer with documented PSA progression, with a calculated PSA doubling time 70
- Is greater than 18 years of age
- Must meet specific lab values for the following criteria: granulocyte, platelet count, total bilirubin, AST and ALT, serum creatinine, calculated creatinine clearance & urinalysis (see protocol for specific detail).
- If fertile, the patient has agreed to use an acceptable method of birth control to avoid fathering a child for the duration of the study and for a period of 2 months thereafter.
- Has signed a Patient Informed Consent Form
- Has signed a Patient Authorization Form
EXCLUSION CRITERIA
- Has only clinical progression without evidence of PSA progression
- Has received prior chemotherapy
- Has had prior treatment with Vidaza
- Has a history of hypersensitivity to any component of Vidaza (mannitol)
- Has a history of New York Heart Association (NYHA) heart disease Class III or IV (Appendix III) or myocardial infarction within 6 months prior to Day 1 or unstable arrhythmia or evidence of ischemia on electrocardiogram (ECG)
- Is receiving concurrent immunotherapy
- Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult.
- Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 1 month prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
- Has evidence of central nervous system (CNS) involvement
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection that requires systemic therapy
- Has a serious uncontrolled nonmalignant disease (liver failure, or other condition) that could compromise protocol objectives in the opinion of the Investigator
- Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
- Is known to be positive for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Is unable to comply with requirements of study
Data sourced from ClinicalTrials.gov (NCT00384839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.