Prostate CancerPhase 2NCT00060437
Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer
A Phase 2 study testing perifosine in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- perifosine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- perifosine
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perifosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startOct 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Edwin M. Posadas, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060437
- Sponsor's protocol ID
- CDR0000301951
- Other IDs
- NCI-03-C-0157, NCI-5970
- Status last verified
- Apr 2004
- First submitted
- 6 May 2003
- Last updated
- 19 Jun 2013
- Results posted
- No
Publications
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.
PubMed 16138006Posadas 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00060437
- Acronym / sponsor ID
- CDR0000301951
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perifosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Results publication: PubMed 16138006Posadas 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 publicationPosadas 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.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin M. Posadas, MD study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perifosine in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060437, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.