Trial Outcomes & Findings for Perifosine in Treating Patients With Recurrent Prostate Cancer (NCT NCT00058214)

Last Updated: 2015-02-23

Results Overview

A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (\< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient's best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was \< 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2015-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Perifosine) Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Perifosine) Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
Overall Study Adverse Event	1

Baseline Characteristics

Perifosine in Treating Patients With Recurrent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Perifosine) n=25 Participants Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome measures
Measure	Treatment (Perifosine) n=24 Participants Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
PSA Response	0 percentage of participants

SECONDARY outcome

Timeframe: From the date of registration to the date of documented PSA progression, assessed up to 6 years

Estimated using the product-limit method of Kaplan and Meier. Progression was defined as the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was \< 2 months.

Outcome measures

Outcome measures
Measure	Treatment (Perifosine) n=25 Participants Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
Time to Progression	6.64 months Interval 4.53 to 12.81

Adverse Events

Treatment (Perifosine)

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Perifosine) n=25 participants at risk Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
Musculoskeletal and connective tissue disorders Bone pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Treatment (Perifosine) n=25 participants at risk Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. perifosine: Given orally laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Hemoglobin decreased	28.0% 7/25 • Number of events 20 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Keratitis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Photophobia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	64.0% 16/25 • Number of events 27 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	8.0% 2/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	12.0% 3/25 • Number of events 8 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Melaena	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	28.0% 7/25 • Number of events 13 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders	12.0% 3/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	12.0% 3/25 • Number of events 4 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	48.0% 12/25 • Number of events 17 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Oedema NOS	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	12.0% 3/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection, Viral (COH)	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	8.0% 2/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	16.0% 4/25 • Number of events 7 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	4.0% 1/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercholesterolemia	4.0% 1/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	8.0% 2/25 • Number of events 9 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	16.0% 4/25 • Number of events 8 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	16.0% 4/25 • Number of events 7 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	24.0% 6/25 • Number of events 6 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	40.0% 10/25 • Number of events 28 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	4.0% 1/25 • Number of events 4 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	8.0% 2/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperuricemia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	8.0% 2/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	4.0% 1/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	8.0% 2/25 • Number of events 5 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	16.0% 4/25 • Number of events 5 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	12.0% 3/25 • Number of events 5 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	24.0% 6/25 • Number of events 7 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	8.0% 2/25 • Number of events 4 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ischemia cerebrovascular	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neurological disorder NOS	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urogenital disorder	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • Number of events 2 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.0% 3/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hiccough	12.0% 3/25 • Number of events 4 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	8.0% 2/25 • Number of events 3 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	24.0% 6/25 • Number of events 10 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	4.0% 1/25 • Number of events 1 • Adverse events were collected over a 60 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60