Adenocarcinoma of the ProstatePhase 2NCT00080899
Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer
A Phase 2 study testing fenretinide 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
This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
- What is being tested?
- fenretinide 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate
- Patients must have a rising PSA, following a nadir value of < 4 ng/mL for patients treated with primary radiation and < 0.3 ng/mL for patients treated with radical prostatectomy, with no clinical or radiographic evidence of metastatic disease; the rising PSA must be confirmed by two consecutive increases, separated by at least 2 weeks; the absolute PSA value must be > 2.0 ng/mL, and the increment of increase must be at least 0.5 ng/mL above the nadir
- Following radical prostatectomy, patients can have received adjuvant radiation therapy for positive margins or pT3 disease; patients may also have received radiation therapy for local recurrence, provided that they subsequently have a rising PSA after a new PSA nadir of < 4ng/mL
- Bone scan negative for metastatic disease within 4 weeks prior to registration
- Patients must have a performance status of 0, 1, or 2
- The effects of fenretinide on fetal conception and development at the recommended therapeutic dose are unknown; for this reason, men enrolled in this trial must agree to use adequate contraception prior to study entry and for the duration of study participation
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- Peripheral absolute neutrophil count (ANC) >= 1000/μL
- Platelet count >= 100,000/μL (transfusion independent; defined as: without transfusion for 3 weeks prior to obtaining study entry value)
- Hemoglobin >= 8.0 gm/dL (may receive RBC transfusions or exogenous erythropoietin)
- Life expectancy of greater than 3 months
- Serum creatinine =< 1.5 gm/dL
- Creatinine clearance or radioisotope GFR >= 50 ml/min/m2
- Total bilirubin =< 1.5 mg/dL
- SGOT (AST) and SGPT (ALT) < 2.5 x normal
- Patients with seizure disorders may be enrolled if on anticonvulsants and well controlled
- CNS toxicity =< Grade 2
- Patient must be able to consume the entire intact capsule(s) in the dosage prescribed for body surface area
- Triglycerides are less than 300mg/dl
- All patients will have malignancy confirmed by review of their biopsy specimens by the Division of Pathology of the City of Hope National Medical Center, the University of Southern California/LA County/Norris Comprehensive Cancer Center, or the University of California at Davis
- In patients who received radiotherapy, the absolute increase of PSA must be at least 2ng/ml to account for the "bounce" phenomenon
Who cannot join
- Patients with evidence of metastatic disease
- PSA progression not verified by sequential rising PSA as discussed in Eligibility section
- Inability to take oral fenretinide
- Patients who have had prior cytotoxic chemotherapy or androgen ablative therapy
- Patients with history of receiving, or current administration of, chemotherapeutic agents, biological response modifiers, or corticosteroids; patients are permitted to have received up to 9 months of neoadjuvant or adjuvant hormone ablation in conjunction with their primary definitive therapy; androgen deprivation must have been completed at least one year prior to registration; no complementary or alternative therapy (e.g. St. John's Wort, PC-SPES, or 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 fenretinide (i.e. retinoids)
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- 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
- 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
- Patients should not take any drugs suspected of causing pseudotumor cerebri, which include tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, amiodarone, or vitamin A
- Patients may have received one prior investigational anti-cancer agent
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from this study because of possible pharmacokinetic interactions with fenretinide; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- Patients should not concurrently take medications that may potentially act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, or p-glycoprotein (MDR1) or MRP1 drug/lipid transporters, such as: cyclosporine A or analogue; verapamil; tamoxifen or analogue; ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone
- Patients with known uncontrolled hypertriglyceridemia resulting in pancreatitis are excluded from study; patients with fasting triglycerides equal to or greater then 300mg/dl should start on medical treatment for hypertriglyceridemia (ex. fibrate derivatives); fenretinide will only be started when triglycerides are less than 300mg/dl
- Patients with known retinopathy from any source are excluded from the protocol as elevated ceramide levels from Fenretinide may exacerbate and/or lead to permanent retinal damage in this population
- Patients taking antioxidant supplements (vitamin C or E) must discontinue use before being eligible for protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California, Norris
Los Angeles, California, 90033
About this study
Official title: A Phase II Trial of Fenretinide (4-HPR) in Biochemically Recurrent, Hormone Naive Prostate Cancer
This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in 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 fenretinide (4-HPR).
II. To assess PSA doubling time as a measure of disease activity, time to PSA progression in prostate cancer patients receiving fenretinide.
III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population.
IV. To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs > 10 ng/mL).
Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
- Being tested
- fenretinide, 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.
fenretinideDrug
Also called fenretinimide, McN-R-1967
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (fenretinide) | Experimental | Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Receives: Drug: fenretinide; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response
PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.
Measured: Baseline to 5 years
Secondary outcomes (1)
Time to PSA Progression
Was summarized using the product-limit (Kaplan-Meier) method. In patients whose PSA levels initially decreased, PSA progression was defined as a 25% increase over the nadir (postenrollment PSA value up to that point), and an increase in the absolute value in the PSA value of 5 ng/mL, relative to the lowest postenrollment PSA value up to that point, including the baseline PSA level - and which was confirmed by second value 3-4 weeks later. A best response of PSA-PD was recorded for those patients who did not achieve a confirmed PSA-N or PSA-PR and who experienced PSA progression within 3 months of start of treatment.
Measured: From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startJun 2004
- Primary completionJan 2009
- Study completionJan 2009
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jacek Pinski, MD, Principal investigator, University of Southern California, Norris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080899
- Sponsor's protocol ID
- NCI-2012-02833
- Other IDs
- PHII-47, N01CM62209, CDR0000357312
- Status last verified
- Feb 2013
- First submitted
- 7 Apr 2004
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Fenretinide (4-HPR) in Biochemically Recurrent, Hormone Naive Prostate Cancer
- ClinicalTrials.gov ID
- NCT00080899
- Acronym / sponsor ID
- NCI-2012-02833
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Apr 2004 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in 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 fenretinide (4-HPR).
II. To assess PSA doubling time as a measure of disease activity, time to PSA progression in prostate cancer patients receiving fenretinide.
III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population.
IV. To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs > 10 ng/mL).
Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (fenretinide) | Experimental | Drug: fenretinide, Other: laboratory biomarker analysisPatients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate
- Patients must have a rising PSA, following a nadir value of < 4 ng/mL for patients treated with primary radiation and < 0.3 ng/mL for patients treated with radical prostatectomy, with no clinical or radiographic evidence of metastatic disease; the rising PSA must be confirmed by two consecutive increases, separated by at least 2 weeks; the absolute PSA value must be > 2.0 ng/mL, and the increment of increase must be at least 0.5 ng/mL above the nadir
- Following radical prostatectomy, patients can have received adjuvant radiation therapy for positive margins or pT3 disease; patients may also have received radiation therapy for local recurrence, provided that they subsequently have a rising PSA after a new PSA nadir of < 4ng/mL
- Bone scan negative for metastatic disease within 4 weeks prior to registration
- Patients must have a performance status of 0, 1, or 2
Key exclusion criteria (15 listed)
- Patients with evidence of metastatic disease
- PSA progression not verified by sequential rising PSA as discussed in Eligibility section
- Inability to take oral fenretinide
- Patients who have had prior cytotoxic chemotherapy or androgen ablative therapy
- Patients with history of receiving, or current administration of, chemotherapeutic agents, biological response modifiers, or corticosteroids; patients are permitted to have received up to 9 months of neoadjuvant or adjuvant hormone ablation in conjunction with their primary definitive therapy; androgen deprivation must have been completed at least one year prior to registration; no complementary or alternative therapy (e.g. St. John's Wort, PC-SPES, or other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment
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 |
|---|---|---|
| fenretinideAlso: fenretinimide, McN-R-1967Given orally | Drug | Treatment (fenretinide) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (fenretinide) |
Primary outcome
PSA Response
Time frame: Baseline to 5 years
PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.
1 secondary outcome
Time to PSA Progression
Time frame: From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Jacek Pinski, MD principal investigator
University of Southern California, Norris
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 fenretinide 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 20 inclusion and 15 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: finished, as of the sponsor's last update on 6 Mar 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 6 Mar 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: Baseline to 5 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 6 Mar 2015.