Phase 2
Completed N=29
Vorinostat in Treating Patients With Progressive Metastatic Prostate Cancer
Recurrent Prostate Cancer · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT00330161 ↗
Enrolled (actual)
29
Serious AEs
27.6%
Results posted
May 2014
Primary outcomePrimary: Proportion of Patients Who do Not Demonstrate Disease Progression
Summary
This phase II trial is studying how well vorinostat works in treating patients with progressive metastatic prostate cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who do Not Demonstrate Disease Progression |
— | — |
| SECONDARY Incidence of Toxicity |
48 | — |
| SECONDARY Rate of PSA Decline |
— | — |
| SECONDARY Progression-free Survival |
2.8 | — |
| SECONDARY Median Survival |
11.7 | — |
| SECONDARY Objective Response Rate |
7 | — |
Eligibility Criteria
Inclusion Criteria
- A histologic or cytologic diagnosis of prostate cancer
- Metastatic prostate cancer with measurable and/or bony disease that has progressed despite androgen deprivation therapy and one prior chemotherapy for castrate metastatic disease; all patients must have PSA progression defined as:
- At least 2 rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) must be taken at least 7 days after the reference value; a third confirmatory PSA measure is required to be greater than the second measure and must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA is required to be taken and be greater then the 2nd measure
- All patients must have a minimum PSA of >= 5 ng/ml
- ECOG performance status of 0-2
- Testosterone = 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Serum creatinine 45% and there is no evidence of ventricular aneurysm or other abnormal wall motion; patients with an ejection fraction < 45% on RNCA, with a worrisome but nonexclusive cardiovascular history, or an abnormal ECG as described above should also have a thallium stress test
- STRESS TEST RESULTS:
- Reversible defect - Exclude
- Fixed defect alone - Include
Data sourced from ClinicalTrials.gov (NCT00330161). 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.