Trial Outcomes & Findings for Vorinostat in Treating Patients With Progressive Metastatic Prostate Cancer (NCT NCT00330161)
NCT ID: NCT00330161
Last Updated: 2014-05-26
Results Overview
Fisher's Exact Test will be used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
At 6 months
Results posted on
2014-05-26
Participant Flow
Participants were recruited at 5 medical centers between May 2006 and February 2007.
Participant milestones
| Measure |
Treatment (Vorinostat)
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vorinostat in Treating Patients With Progressive Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Vorinostat)
n=27 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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|---|---|
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Age, Continuous
Age
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68 years
n=99 Participants
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Sex: Female, Male
Female
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0 Participants
n=99 Participants
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Sex: Female, Male
Male
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27 Participants
n=99 Participants
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Region of Enrollment
United States
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27 participants
n=99 Participants
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PRIMARY outcome
Timeframe: At 6 monthsPopulation: The primary objective was to determine the number of patients wtih progression-free survival at 6 months. Unfortunately all eligible patients were off therapy before the 6 month time point. 13 (48%) were removed due to progression, 11 (41%) secondary to toxicity, and 3 (11%) for other reasons.
Fisher's Exact Test will be used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Of the 29 patients enrolled, 2 were deemed ineligible after treatment and therefore excluded from outcome analysis.
The percentage of eligible participants that experience grade 3 or 4 toxicities.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=27 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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Incidence of Toxicity
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48 percentage of participants
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: No PSA declines of greater than or equal to 50% were observed, therefore the rate could not be determined.
Rate of Prostate Specific Antigen (PSA) decline of greater than or equal to 50%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of treatment to time of progression, assessed up to 3 yearsPopulation: Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.
Median time to progression was determined.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=27 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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|---|---|
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Progression-free Survival
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2.8 months
Interval 0.5 to 5.3
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis. Of the 27 patients analyzed, one patient was censored with an outlying overall survival of 15.1 months.
Median overall survival.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=26 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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|---|---|
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Median Survival
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11.7 months
Interval 2.3 to 14.0
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.
Percentage of participants that obtain the best objective response, stable disease.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=27 Participants
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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Objective Response Rate
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7 percentage of participants
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Adverse Events
Treatment (Vorinostat)
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Vorinostat)
n=29 participants at risk
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Cardiac disorders
Arrhythmia
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Musculoskeletal and connective tissue disorders
Back Pain
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Investigations
Creatinine Increased
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Metabolism and nutrition disorders
Dehydration
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Renal and urinary disorders
Hemorrhage Urinary Tract
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Infections and infestations
Infection, Bone (Osteomyelitis)
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Nausea
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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General disorders
Pain
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Respiratory, thoracic and mediastinal disorders
Pneumonitis
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Proctitis
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Infections and infestations
Skin Infection
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Vascular disorders
Thrombosis
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Vomiting
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3.4%
1/29 • Number of events 1 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Other adverse events
| Measure |
Treatment (Vorinostat)
n=29 participants at risk
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
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|---|---|
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Gastrointestinal disorders
Abdominal Distention
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Investigations
Activated Partial Thromboplastin Time Prolonged
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6.9%
2/29 • Number of events 18 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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|
Investigations
Alanine Aminotransferase Increased
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17.2%
5/29 • Number of events 5 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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|
Investigations
Alkaline Phosphatase Increased
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27.6%
8/29 • Number of events 8 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Skin and subcutaneous tissue disorders
Alopecia
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Metabolism and nutrition disorders
Anorexia
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72.4%
21/29 • Number of events 36 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Musculoskeletal and connective tissue disorders
Arthritis
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Investigations
Aspartate Aminotransferase Increased
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20.7%
6/29 • Number of events 14 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Renal and urinary disorders
Bladder Hemorrhage
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Musculoskeletal and connective tissue disorders
Bone Pain
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13.8%
4/29 • Number of events 4 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Constipation
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17.2%
5/29 • Number of events 8 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Diarrhea
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37.9%
11/29 • Number of events 18 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Dry Mouth
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13.8%
4/29 • Number of events 4 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Dyspepsia
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Gastrointestinal disorders
Dysphagia
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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10.3%
3/29 • Number of events 4 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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General disorders
Edema Limbs
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6.9%
2/29 • Number of events 3 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Reproductive system and breast disorders
Erectile Dysfunction
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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General disorders
Fatigue
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86.2%
25/29 • Number of events 57 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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General disorders
Fever
|
10.3%
3/29 • Number of events 3 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Ear and labyrinth disorders
Hearing Loss
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6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Blood and lymphatic system disorders
Anemia
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37.9%
11/29 • Number of events 19 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Vascular disorders
Hot Flashes
|
6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.9%
11/29 • Number of events 24 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.9%
2/29 • Number of events 3 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.3%
3/29 • Number of events 5 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
General disorders
Hypersensitivity
|
6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.7%
6/29 • Number of events 12 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.3%
3/29 • Number of events 3 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
3/29 • Number of events 5 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.3%
3/29 • Number of events 5 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Investigations
INR Increased
|
10.3%
3/29 • Number of events 28 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
6.9%
2/29 • Number of events 3 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Investigations
Leukopenia (White Blood Cells Decreased)
|
13.8%
4/29 • Number of events 12 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Investigations
Lymphopenia
|
10.3%
3/29 • Number of events 4 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Gastrointestinal disorders
Mucositis Oral
|
10.3%
3/29 • Number of events 4 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
General disorders
Pain
|
6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
17.2%
5/29 • Number of events 6 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Investigations
Platelet Count Decreased
|
51.7%
15/29 • Number of events 20 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Nervous system disorders
Taste Alteration
|
20.7%
6/29 • Number of events 7 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Renal and urinary disorders
Urinary Frequency
|
17.2%
5/29 • Number of events 9 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
|
|
Investigations
Weight Decreased
|
31.0%
9/29 • Number of events 11 • Serious Adverse Events (SAEs) were reported that occurred within 30 days of the last dose of study drug.
All patients were evaluable for toxicity from the time of their first treatment with SAHA.
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Additional Information
Erin Sargent
University of Michigan Comprehensive Cancer Center
Phone: (734) 936-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60