Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 recurrent prostate cancer.

Further Study Information

OBJECTIVES:

• Determine the prostate-specific antigen (PSA) response to perifosine in patients with hormone-sensitive prostate cancer who have a biochemical recurrence after prior local curative therapy.

• Compare the 6-month increase in PSA levels with baseline in patients treated with this drug.

• Determine the PSA doubling time and time to PSA progression in patients treated with this drug.

• Determine the qualitative and quantitative toxic effects of this drug in these patients.

• Identify potential molecular markers predictive of decreased PSA doubling time and, possibly, PSA response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy with or without brachytherapy vs surgery and radiotherapy) and original combined Gleason score (7 or less vs 8-10).

Patients receive oral perifosine once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine. 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.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Biochemical recurrence

• Rising prostate-specific antigen (PSA) of at least 2.0 ng/mL following a nadir after local curative therapy (radical prostatectomy and/or pelvic radiotherapy)

• Rising PSA must be confirmed by 2 consecutive increases measured at least 2 weeks apart

• No evidence of local or distant relapse by physical exam or radiography

• No clinical or radiographic evidence of metastatic disease by all of the following:

• CT scan or MRI of the pelvis

• Bone scan

• Posterior, anterior, and lateral x-ray

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• 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 no greater than 1.5 mg/dL

• AST and ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Fertile patients must use effective contraception

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to perifosine

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or adequately treated stage I or II cancer currently in complete remission

• No ongoing or active infection

• No other concurrent uncontrolled illness

• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 6 months since prior vaccine therapy

• No concurrent biological response modifiers

Chemotherapy

• No prior cytotoxic chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• Prior adjuvant or neoadjuvant hormonal therapy allowed provided treatment duration was no longer than 9 months*

• At least 1 year since prior neoadjuvant or adjuvant androgen deprivation therapy*

• No concurrent corticosteroids

• No concurrent hormonal therapy NOTE: *No rising PSA at the time therapy was discontinued

Radiotherapy

• See Disease Characteristics

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent investigational agents

• No other concurrent anticancer agents or therapies (investigational or commercial)

• No concurrent complementary or alternative therapy (e.g., Hypericum perforatum [St. John's Wort], PC-SPES, or any other herbal remedy for the treatment of prostate cancer)

• No concurrent combination antiretroviral therapy for HIV-positive patients

Trial Contact Information

Trial Lead Organizations/Sponsors

California Cancer Consortium

Primo N. Lara

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00058214
Information obtained from ClinicalTrials.gov on December 14, 2011

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