Prostate CancerPhase 2NCT00557037
A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer
A Phase 2 study testing Phenoxodiol in people with Prostate Cancer, run by MEI Pharma, Inc. at 2 sites in United States.
Trial summary
Two groups of patients with prostate cancer will be enrolled: Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has not had any chemotherapy. 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?
- Phenoxodiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Nov 2009
- 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
Who may be able to join
- All patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
- Patients with castrate and non-castrate levels of testosterone are eligible as defined below.
- Patients with castrate level of testosterone (Group A- androgen independent disease) need to meet the following criteria:
- Progressive disease based on any one of the following
- a rise in PSA, b) transaxial imaging, or c) radionuclide bone scan. Patients whose sole manifestation of progression is an increase in disease related symptoms are not eligible.
- PSA - a minimum of 3 consecutive rising levels, with an interval of > 1 week between each determination. The last determination must have a minimal value of > 4 ng/ml and be determined within two weeks prior to registration.
Show all 36Show fewer
- Measurable Disease: Patient showing new or progressive soft tissue masses on CT or MRI scans are eligible.
- Radionuclide bone scan: New metastatic lesions.
- Serum testosterone < 50 ng/ml, determined within two weeks prior to starting treatment
- Maintaining castrate status: Patients who have not undergone surgical orchiectomy should continue on medical therapies [i.e. gonadotropin releasing hormone analogs (GnRH analogs) to maintain castrate levels of serum testosterone. Patients who are receiving an anti-androgen as part of their first-line hormonal therapy must have shown progression of disease off of the anti-androgen prior to enrollment. Patients must discontinue Megestrol Acetate (MEGACE) and show progression of disease off of this medication.
- No prior chemotherapy except for adjuvant or neo-adjuvant therapy given > than 3 years prior to enrollment
- No more than one prior course of palliative radiotherapy. No prior radioisotope therapy with Strontium-89 or Samarium.
- Patients with non-castrate levels of testosterone (Group B- androgen dependent disease) need to meet the following criteria:
- A rising PSA after radical prostatectomy, radiotherapy or radiation implants with no evidence of metastatic disease on bone, CT scan or MRI scan.
- PSA doubling time less than 12 months
- Testosterone level > 50 ng/ml
- Age > 18 years of age.
- Karnofsky Performance Status > 70%
- Four weeks since major surgery.
- Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
- Required Initial Laboratory Data:
- WBC > 3,000/µl
- ANC > 1,500/µl
- Hemoglobin > 9 g/dl
- Platelet count > 100,000/µl
- Creatinine < 1.5 x upper limits of normal
- Bilirubin within 2 x normal limits
- SGOT (AST) < 2.5 x upper limits of normal
- SGPT (AST) < 2.5 x upper limits of normal
- PSA > 4.0 ng/ml (if no measurable disease for Group B) > 4.0 ng/ml for Group A
- PT within normal limits(*)
- PTT within normal limits(*)
- ()unless patients are already anti-coagulated for other reasons (i.e. atrial fibrillation, etc.)
- Agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation and for additional 1 months after finishing Phenoxodiol.
- Able to swallow and retain oral medication
- Life expectancy >3 months
Who cannot join
- Patients may not be receiving any other investigational agents.
- Patients may continue on a daily Multi-Vitamin and Calcium supplements but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration.
- Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of PXD. Prophylactic use of bisphosphonates in patients without bone disease, except for the treatment of osteoporosis, and initiation of bisphosphonates during study treatment is not permitted.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months) are excluded.
- Patients with prior history of hemorrhagic or thrombotic cerebral vascular accident, deep venous thrombosis or pulmonary embolism within the past 6 months are excluded.
Show all 9Show fewer
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse.
- 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.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Phenoxodiol. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Cancer Center
New Haven, Connecticut, 06520
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Two groups of patients with prostate cancer will be enrolled:
Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has not had any chemotherapy.
Read more
Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do not have any spread to the bones or other organs.
Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1 cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment (immediately prior to cycle 4). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for a total of 12 cycles(approximately 12 months).
- Conditions
- Prostate Cancer
- Being tested
- Phenoxodiol
- Keywords
- Castrate and Non-Castrate Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenoxodiolDrug
Oral capsule, 400 mg every 8 hours daily, for 12 weeks - assement to a maximum of 12 months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients with chemotherapy naïve androgen independent disease Receives: Drug: Phenoxodiol |
| B | Experimental | Patients with rising PSA after radical prostatectomy or radiotherapy that are androgen dependent Receives: Drug: Phenoxodiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients that have a 50% post-therapy PSA decline at 12 weeks in patients with: a)Chemotherapy naïve androgen independent disease (Group A) b)Rising PSA after radical prostatectomy or radiotherapy that are androgen dependent (Group B)
Measured: 12 weeks
Secondary outcomes (1)
To determine the proportion of patients treated with Phenoxodiol that has measurable disease regression at 12 weeks in patients with chemotherapy naïve androgen independent disease.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startNov 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MEI Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kevin Kelly, MD, Principal investigator, Yale New Haven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557037
- Sponsor's protocol ID
- Yale 0703002467
- Status last verified
- Apr 2010
- First submitted
- 8 Nov 2007
- Last updated
- 8 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Phenoxodiol in Patients With Castrate and Non-Castrate Prostate Cancer
- ClinicalTrials.gov ID
- NCT00557037
- Acronym / sponsor ID
- Yale 0703002467
- Conditions
- Prostate Cancer
- Keywords
- Castrate and Non-Castrate Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MEI Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Nov 2007 (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.
Two groups of patients with prostate cancer will be enrolled:
Group A: patients whose cancer has worsened or spread after being on hormonal therapy and has not had any chemotherapy.
Group B: patients who have a rising PSA after surgery or radiotherapy for the prostate and do not have any spread to the bones or other organs.
Patients will receive Phenoxodiol (PXD) 400 mg every 8 hours daily for 28 consecutive days (1 cycle). Treatment outcome will be evaluated after three cycles (12 weeks) of PXD treatment (immediately prior to cycle 4). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for a total of 12 cycles(approximately 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PhenoxodiolPatients with chemotherapy naïve androgen independent disease |
| B | Experimental | Drug: PhenoxodiolPatients with rising PSA after radical prostatectomy or radiotherapy that are androgen dependent |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- All patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
- Patients with castrate and non-castrate levels of testosterone are eligible as defined below.
- Patients with castrate level of testosterone (Group A- androgen independent disease) need to meet the following criteria:
- Progressive disease based on any one of the following
- Serum testosterone < 50 ng/ml, determined within two weeks prior to starting treatment
Key exclusion criteria (9 listed)
- Patients may not be receiving any other investigational agents.
- Patients may continue on a daily Multi-Vitamin and Calcium supplements but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration.
- Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of PXD. Prophylactic use of bisphosphonates in patients without bone disease, except for the treatment of osteoporosis, and initiation of bisphosphonates during study treatment is not permitted.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months) are excluded.
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 |
|---|---|---|
| PhenoxodiolOral capsule, 400 mg every 8 hours daily, for 12 weeks - assement to a maximum of 12 months | Drug | A, B |
Primary outcome
The proportion of patients that have a 50% post-therapy PSA decline at 12 weeks in patients with: a)Chemotherapy naïve androgen independent disease (Group A) b)Rising PSA after radical prostatectomy or radiotherapy that are androgen dependent (Group B)
Time frame: 12 weeks
1 secondary outcome
To determine the proportion of patients treated with Phenoxodiol that has measurable disease regression at 12 weeks in patients with chemotherapy naïve androgen independent disease.
Time frame: 12 weeks
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 8 Apr 2010.
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.
Kevin Kelly, MD principal investigator
Yale New Haven Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenoxodiol in people with Prostate Cancer, run by MEI Pharma, Inc. at 2 sites 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 36 inclusion and 9 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 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
The proportion of patients that have a 50% post-therapy PSA decline at 12 weeks in patients with: a)Chemotherapy naïve androgen independent disease (Group A) b)Rising PSA after radical prostatectomy or radiotherapy that are androgen dependent (Group B) (time frame: 12 weeks). 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 8 Apr 2010.