Trial Outcomes & Findings for Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00460031)
NCT ID: NCT00460031
Last Updated: 2020-07-24
Results Overview
Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) \>= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
28 days
Results posted on
2020-07-24
Participant Flow
Thirty seven (37) patients were screened from Cleveland Clinic and University Hospitals in the Cleveland area from February 2007 to April 2009.Three patients were not eligible.
Participant milestones
| Measure |
Ketoconazole Plus Lenalidomide
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Ketoconazole Plus Lenalidomide
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Ketoconazole Plus Lenalidomide
n=34 Participants
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Age, Customized
40-49 years
|
2 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
5 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
10 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
11 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All patients who completed the study
Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) \>= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.
Outcome measures
| Measure |
Ketoconazole Plus Lenalidomide
n=23 Participants
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease
Partial Response
|
7 participants
|
|
Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease
Progressive Disease
|
7 participants
|
|
Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease
Stable Disease
|
9 participants
|
SECONDARY outcome
Timeframe: One year (12 months) after start of treatmentPopulation: Patients with disease progression
Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) \>= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.
Outcome measures
| Measure |
Ketoconazole Plus Lenalidomide
n=7 Participants
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Time to Progression
|
3 Months
Interval -1.52 to 7.52
|
SECONDARY outcome
Timeframe: Up to 30 days after discontinuation of treatmentPopulation: All patients who received at least one treatment in the study
Patients will be evaluated for toxicity every 2 weeks during the first cycle. Thereafter, evaluations will be done every 28 days or more frequently if clinically indicated.
Outcome measures
| Measure |
Ketoconazole Plus Lenalidomide
n=34 Participants
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0
|
19 participants
|
SECONDARY outcome
Timeframe: Week 8Population: All patients who completed the study
The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the levels of CD4+ FoxP3+ Regulatory T cells
Outcome measures
| Measure |
Ketoconazole Plus Lenalidomide
n=23 Participants
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Change in Immune Response From Baseline
|
0.18 cells/ul
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Week 8Population: All patients who completed the study
The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the ratio of BDCA-2 to BDCA-1 cells
Outcome measures
| Measure |
Ketoconazole Plus Lenalidomide
n=23 Participants
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Ratio of Change in Immune Response From Baseline
|
-0.39 ratio
Standard Deviation 1.44
|
Adverse Events
Ketoconazole Plus Lenalidomide
Serious events: 12 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketoconazole Plus Lenalidomide
n=34 participants at risk
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
2.9%
1/34 • 30 Days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.9%
2/34 • 30 Days
|
|
Cardiac disorders
Cardiovascular/Arrhythmia
|
2.9%
1/34 • 30 Days
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
2.9%
1/34 • 30 Days
|
|
Cardiac disorders
Cardiovascular/General
|
5.9%
2/34 • 30 Days
|
|
General disorders
Edema
|
2.9%
1/34 • 30 Days
|
|
Blood and lymphatic system disorders
Coagulation
|
2.9%
1/34 • 30 Days
|
|
General disorders
Constitutional Symptoms
|
2.9%
1/34 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
2.9%
1/34 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.9%
1/34 • 30 Days
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • 30 Days
|
|
Gastrointestinal disorders
dehydration
|
2.9%
1/34 • 30 Days
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
5.9%
2/34 • 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
3/34 • 30 Days
|
|
Investigations
Bilirubin
|
2.9%
1/34 • 30 Days
|
|
Hepatobiliary disorders
Liver dysfunction
|
2.9%
1/34 • 30 Days
|
|
Hepatobiliary disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
2.9%
1/34 • 30 Days
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
2.9%
1/34 • 30 Days
|
|
Blood and lymphatic system disorders
Infection/Febrile Neutropenia
|
2.9%
1/34 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
2.9%
1/34 • 30 Days
|
|
Nervous system disorders
Dizziness/lightheadedness
|
5.9%
2/34 • 30 Days
|
|
Nervous system disorders
Neuropathy-sensory
|
2.9%
1/34 • 30 Days
|
|
Eye disorders
Vision-blurred vision
|
2.9%
1/34 • 30 Days
|
|
Renal and urinary disorders
Renal failure
|
2.9%
1/34 • 30 Days
|
|
General disorders
Fatigue (Lethargy, malaise, asthenia)
|
2.9%
1/34 • 30 Days
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.9%
1/34 • 30 Days
|
Other adverse events
| Measure |
Ketoconazole Plus Lenalidomide
n=34 participants at risk
Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
|
|---|---|
|
General disorders
"Fatigue (lethargy, malaise, asthenia)"
|
79.4%
27/34 • Number of events 50 • 30 Days
|
|
General disorders
General Disorders
|
14.7%
5/34 • Number of events 7 • 30 Days
|
|
General disorders
"Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)"
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
General disorders
Weight loss
|
8.8%
3/34 • Number of events 10 • 30 Days
|
|
General disorders
"Rigors, chills"
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
General disorders
Sweating (diaphoresis)
|
5.9%
2/34 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Nausea
|
41.2%
14/34 • Number of events 18 • 30 Days
|
|
Gastrointestinal disorders
Anorexia
|
29.4%
10/34 • Number of events 12 • 30 Days
|
|
Gastrointestinal disorders
Constipation
|
29.4%
10/34 • Number of events 12 • 30 Days
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
23.5%
8/34 • Number of events 9 • 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
20.6%
7/34 • Number of events 9 • 30 Days
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
14.7%
5/34 • Number of events 7 • 30 Days
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Flatulence
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Dehydration
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Gastrointestinal disorders
Gastrointestinal
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Gastrointestinal disorders
Mouth dryness
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Investigations
Hemoglobin
|
52.9%
18/34 • Number of events 38 • 30 Days
|
|
Investigations
Lymphopenia
|
50.0%
17/34 • Number of events 61 • 30 Days
|
|
Blood and lymphatic system disorders
Platelets
|
38.2%
13/34 • Number of events 37 • 30 Days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
35.3%
12/34 • Number of events 47 • 30 Days
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
29.4%
10/34 • Number of events 30 • 30 Days
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
11.8%
4/34 • Number of events 4 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
47.1%
16/34 • Number of events 28 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
29.4%
10/34 • Number of events 14 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
20.6%
7/34 • Number of events 8 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.6%
7/34 • Number of events 8 • 30 Days
|
|
Injury, poisoning and procedural complications
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
8.8%
3/34 • Number of events 4 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
41.2%
14/34 • Number of events 34 • 30 Days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.5%
8/34 • Number of events 14 • 30 Days
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
23.5%
8/34 • Number of events 18 • 30 Days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.6%
6/34 • Number of events 8 • 30 Days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
14.7%
5/34 • Number of events 7 • 30 Days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
4/34 • Number of events 4 • 30 Days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.8%
4/34 • Number of events 4 • 30 Days
|
|
Metabolism and nutrition disorders
Bicarbonate
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
General disorders
Edema
|
38.2%
13/34 • Number of events 18 • 30 Days
|
|
Vascular disorders
Hypertension
|
11.8%
4/34 • Number of events 5 • 30 Days
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Vascular disorders
Thrombosis/embolism
|
8.8%
3/34 • Number of events 4 • 30 Days
|
|
Vascular disorders
Cardiovascular/General
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Investigations
Alkaline phosphatase
|
38.2%
13/34 • Number of events 19 • 30 Days
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
38.2%
13/34 • Number of events 19 • 30 Days
|
|
Investigations
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
32.4%
11/34 • Number of events 17 • 30 Days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
29.4%
10/34 • Number of events 21 • 30 Days
|
|
Investigations
Bilirubin
|
5.9%
2/34 • Number of events 4 • 30 Days
|
|
Nervous system disorders
Dizziness/lightheadedness
|
26.5%
9/34 • Number of events 12 • 30 Days
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • Number of events 5 • 30 Days
|
|
Nervous system disorders
Neuropathy-sensory
|
11.8%
4/34 • Number of events 5 • 30 Days
|
|
Nervous system disorders
Mood alteration-depression
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Nervous system disorders
Neurology-Other
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
35.3%
12/34 • Number of events 17 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
6/34 • Number of events 7 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Investigations
Creatinine
|
29.4%
10/34 • Number of events 20 • 30 Days
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Renal and urinary disorders
Urinary discoloration
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
General disorders
Pain
|
32.4%
11/34 • Number of events 23 • 30 Days
|
|
Cardiac disorders
Chest pain (non-cardiac and non-pleuritic)
|
8.8%
3/34 • Number of events 3 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
23.5%
8/34 • Number of events 15 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
17.6%
6/34 • Number of events 6 • 30 Days
|
|
Blood and lymphatic system disorders
Infection/Febrile Neutropenia
|
17.6%
6/34 • Number of events 10 • 30 Days
|
|
Infections and infestations
Infection without neutropenia
|
14.7%
5/34 • Number of events 6 • 30 Days
|
|
Eye disorders
Dry eye
|
11.8%
4/34 • Number of events 6 • 30 Days
|
|
Eye disorders
Vision-blurred vision
|
11.8%
4/34 • Number of events 6 • 30 Days
|
|
Eye disorders
Ocular/Visual
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Eye disorders
Vision-flashing lights/floaters
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
4/34 • Number of events 5 • 30 Days
|
|
Vascular disorders
Hemorrhage
|
11.8%
4/34 • Number of events 5 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)"
|
11.8%
4/34 • Number of events 4 • 30 Days
|
|
Immune system disorders
Allergy
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Endocrine disorders
Hot flashes/flushes
|
11.8%
4/34 • Number of events 4 • 30 Days
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
2/34 • Number of events 2 • 30 Days
|
|
Blood and lymphatic system disorders
Coagulation
|
8.8%
3/34 • Number of events 4 • 30 Days
|
|
Ear and labyrinth disorders
Auditory/Hearing
|
5.9%
2/34 • Number of events 2 • 30 Days
|
Additional Information
Dr. Jorge Garcia
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-444-7774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place