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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
perifosine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00060437
Brief Title
Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer
Official Title
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
OBJECTIVES: Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine. Determine the side-effect profile of this drug in these patients. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. OUTLINE: Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21. All subsequent courses: Patients receive oral perifosine once daily on days 1-21. In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within approximately 1.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
perifosine

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin M. Posadas, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16138006
Citation
Posadas 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.
Results Reference
result
Citation
Posadas 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.
Results Reference
result

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

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