Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Androgens

Criteria

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 patients