Adenocarcinoma of the ProstatePhase 2NCT00058214
Perifosine in Treating Patients With Recurrent Prostate Cancer
A Phase 2 study testing perifosine and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IIB Prostate Cancer
- What is being tested?
- perifosine and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
- Patients must have a rising PSA >= 2.0 following a nadir after local curative therapy (either radical prostatectomy and/or pelvic radiation) with no clinical or radiographic evidence of metastatic disease; PSA >= 2.0 elevation must be confirmed by two consecutive increases, each measured at least 2 weeks apart; only patients with a biochemical (PSA) recurrence with no physical exam or radiographic evidence of local or distant relapse are eligible
- Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as neither lasted for more than 9 months; androgen deprivation therapy must have been completed at least one year prior to registration; patients could not have had a rising PSA at the time that neoadjuvant or adjuvant therapy was stopped
- Life expectancy of greater than 3 months
- Karnofsky performance status > 60%
- Leukocytes >= 3,000/uL
Show all 17Show fewer
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,00/uL
- Total bilirubin =< 1.5 mg/dL
- AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
- Computed tomography scan or MRI of the pelvis negative for metastatic disease within 3 months prior to registration
- Bone scan negative for metastatic disease within 3 months prior to registration
- Chest PA and lateral films negative for metastatic disease within 3 months prior to registration
- Prior vaccine therapy is allowed if completed at least 6 months prior to registration
- Men enrolled in this trial must agree to use adequate contraception prior to study entry and for the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had any prior cytotoxic chemotherapy
- Patients may not be receiving any other investigational agents
- Patients receiving concurrent chemotherapeutic agents, biological response modifiers, radiation therapy, corticosteroid or hormonal therapy; no complementary or alternative therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine
- Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of any site, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: A Phase II Trial of Perifosine (IND 58,156; NSC# 639966) in Biochemically Recurrent, Hormone Sensitive Prostate Cancer
Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with perifosine.
II. To assess the secondary endpoints of a) six-month increase in PSA levels compared to baseline, b) PSA doubling time and c) time to PSA progression in prostate cancer patients receiving perifosine.
III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population.
IV. To investigate potential molecular markers predictive of decreased PSADT and possibly PSA response in prostate cancer patients receiving perifosine.
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.
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Being tested
- perifosine, laboratory biomarker analysis
- 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
Also called D21266, octadecylphosphopiperidine
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (perifosine) | Experimental | 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. Receives: Drug: perifosine; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response
A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient's best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.
Measured: Up to 6 years
Secondary outcomes (1)
Time to Progression
Estimated using the product-limit method of Kaplan and Meier. Progression was defined as the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months.
Measured: From the date of registration to the date of documented PSA progression, assessed up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Did not meet interim stopping criteria for continuation to the second stage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Primo Lara, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058214
- Sponsor's protocol ID
- NCI-2012-02832
- Other IDs
- PHII-44, N01CM17101, CDR0000287195
- Status last verified
- Feb 2013
- First submitted
- 7 Apr 2003
- Last updated
- 23 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Perifosine (IND 58,156; NSC# 639966) in Biochemically Recurrent, Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT00058214
- Acronym / sponsor ID
- NCI-2012-02832
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet interim stopping criteria for continuation to the second stage.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die
Detailed description
PRIMARY OBJECTIVES:
- To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with perifosine.
II. To assess the secondary endpoints of a) six-month increase in PSA levels compared to baseline, b) PSA doubling time and c) time to PSA progression in prostate cancer patients receiving perifosine.
III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population.
IV. To investigate potential molecular markers predictive of decreased PSADT and possibly PSA response in prostate cancer patients receiving perifosine.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (perifosine) | Experimental | Drug: perifosine, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
- Patients must have a rising PSA >= 2.0 following a nadir after local curative therapy (either radical prostatectomy and/or pelvic radiation) with no clinical or radiographic evidence of metastatic disease; PSA >= 2.0 elevation must be confirmed by two consecutive increases, each measured at least 2 weeks apart; only patients with a biochemical (PSA) recurrence with no physical exam or radiographic evidence of local or distant relapse are eligible
- Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as neither lasted for more than 9 months; androgen deprivation therapy must have been completed at least one year prior to registration; patients could not have had a rising PSA at the time that neoadjuvant or adjuvant therapy was stopped
- Life expectancy of greater than 3 months
- Karnofsky performance status > 60%
Key exclusion criteria (8 listed)
- Patients who have had any prior cytotoxic chemotherapy
- Patients may not be receiving any other investigational agents
- Patients receiving concurrent chemotherapeutic agents, biological response modifiers, radiation therapy, corticosteroid or hormonal therapy; no complementary or alternative therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine
- Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy
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 |
|---|---|---|
| perifosineAlso: D21266, octadecylphosphopiperidineGiven orally | Drug | Treatment (perifosine) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (perifosine) |
Primary outcome
PSA Response
Time frame: Up to 6 years
A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient's best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.
1 secondary outcome
Time to Progression
Time frame: From the date of registration to the date of documented PSA progression, assessed up to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Primo Lara, MD principal investigator
University of California, Davis
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 and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent 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?
The sponsor lists 17 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 23 Feb 2015. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
PSA Response (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.