Clinical trial · Interventional
Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
NCT00060437CI-TRIAL-00010788completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
* Metastatic
* Androgen-independent
* Progressive disease while continuing to receive hormonal ablation (e.g., luteinizing hormone-releasing hormone \[LHRH\] agonist)
* Progression documented by at least 1 of the following parameters:
* Two consecutively rising prostate-specific antigen levels, at least 1 week apart, with at least 1 measurement that is 50% above the nadir reached after the last treatment regimen (as long as the last measurement is at least 5 ng/mL)
* At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy
* Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following:
* Development of new area of malignant disease (measurable or nonmeasurable)
* At least a 20% increase in the sum of the longest diameters (LD) of target lesions from the smallest sum of LD recorded since the treatment started or the appearance of 1 or more new lesions
* Patients who have not undergone surgical castration must have a testosterone level less than 50 ng/mL and continue on their LHRH agonist during study treatment
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No unstable or newly diagnosed angina pectoris
* No New York Heart Association class II-IV congestive heart failure
Ophthalmic
* No pre-existing retinal disease
* No pathologic baseline electrooculogram
Other
* Fertile patients must use effective barrier contraception
* Able to ingest oral medication
* No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine (e.g., miltefosine or edelfosine)
* No ongoing or active infection
* No other concurrent uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* No other active malignancies within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No more than 1 prior chemotherapy regimen
* More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
* See Disease Characteristics
* More than 4 weeks since prior flutamide
* More than 6 weeks since prior bicalutamide or nilutamide
Radiotherapy
* At least 6 weeks since prior bone-seeking radioisotopes
* Recovered from prior radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* Recovered from any acute toxicity related to prior therapy
* More than 3 months since prior UCN-01
* More than 3 months since prior suramin
* No concurrent commercial or other investigational agents or therapies intended to treat the malignancy
* No concurrent combination antiretroviral therapy for HIV-positive patientsReferences
Publications (2)
- RESULTPosadas EM, Gulley J, Arlen PM, Trout A, Parnes HL, Wright J, Lee MJ, Chung EJ, Trepel JB, Sparreboom A, Chen C, Jones E, Steinberg SM, Daniels A, Figg WD, Dahut WL. A phase II study of perifosine in androgen independent prostate cancer. Cancer Biol Ther. 2005 Oct;4(10):1133-7. doi: 10.4161/cbt.4.10.2064. Epub 2005 Oct 1. PMID 16138006
- RESULTPosadas EM, Trout A, Senderowicz AM, et al.: A phase II trial of oral perifosine in patients with metastatic androgen-independent prostate cancer (AIPC). [Abstract] SUO/NCI Urologic Oncology Meeting, December 5-6, 2003, Bethesda, MD. A-54, 38, 2003.