Prostate CancerPhase 2NCT00384839
Vidaza to Restore Hormone Thx Prostate
A Phase 2 study testing azacitidine for injectable suspension in people with Prostate Cancer, run by US Oncology Research at 13 sites in United States.
Trial summary
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow… 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?
- azacitidine for injectable suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2006to Nov 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
- A diagnosis of histologically confirmed, progressive, advanced metastatic, or nonmetastatic prostate cancer with documented PSA progression, with a calculated PSA doubling time <3 months, on complete androgen ablation therapy. PSA progression, with or without clinical progression (symptomatic/radiologic as per RECIST) is required; measurable disease is not required.
- Baseline PSA values must be followed by 2 serial increases at least 2 weeks apart (no upper limit for time for these 2 samples). Calculated PSA doubling time, for the above PSA values must be <3 months. An automated PSA doubling time calculator may be found at www.mskcc.org/mskcc/html/10088.cfm (see study tools).
- Currently on complete androgen ablation hormone therapy (an LHRH agonist plus an antiandrogen) with testosterone level <50ng/dL). Patients who are on LHRH agonist or other antiandrogenic therapy at entry will continue that therapy while on this study. Anti-androgen withdrawal is not necessary and is precluded before enrollment on the trial. The details of that therapy must be recorded in the CRF. Patients who have had an orchiectomy and who are on antiandrogen therapy are permitted on study.
- An elevated PSA level for patients progressing by PSA criteria is required (see protocol for specific detail).
- Has a Karnofsky Performance Status >70
- Is greater than 18 years of age
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- Must meet specific lab values for the following criteria: granulocyte, platelet count, total bilirubin, AST and ALT, serum creatinine, calculated creatinine clearance \& urinalysis (see protocol for specific detail).
- If fertile, the patient has agreed to use an acceptable method of birth control to avoid fathering a child for the duration of the study and for a period of 2 months thereafter.
- Has signed a Patient Informed Consent Form
- Has signed a Patient Authorization Form
Who cannot join
- Has only clinical progression without evidence of PSA progression
- Has received prior chemotherapy
- Has had prior treatment with Vidaza
- Has a history of hypersensitivity to any component of Vidaza (mannitol)
- Has a history of New York Heart Association (NYHA) heart disease Class III or IV (Appendix III) or myocardial infarction within 6 months prior to Day 1 or unstable arrhythmia or evidence of ischemia on electrocardiogram (ECG)
- Is receiving concurrent immunotherapy
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- Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult.
- Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 1 month prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
- Has evidence of central nervous system (CNS) involvement
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection that requires systemic therapy
- Has a serious uncontrolled nonmalignant disease (liver failure, or other condition) that could compromise protocol objectives in the opinion of the Investigator
- Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
- Is known to be positive for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Is unable to comply with requirements of study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
New York Oncology Hematology, P.C.
Albany, New York, 12208
Raleigh Hematology Oncology Associates
Cary, North Carolina, 27511
Texas Oncology, P.A.
Dallas, Texas, 75246
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, 80218
Texas Oncology, P.A.
Fort Worth, Texas, 76104
Northwestern Carolina Oncology Hematology
Hickory, North Carolina, 28602
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761
Cancer Care Nrothwest-South
Spokane, Washington, 99202
Tyler Cancer Center
Tyler, Texas, 75702
Deke Slayton Cancer Center
Webster, Texas, 77598
About this study
Official title: Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.
Read the detailed description
This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days (Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be evaluated prior to each cycle and % fetal hemoglobin will be evaluated prior to each odd cycle (excluding Cycle 1). Patients will be treated until clinical progression up to a maximum of 12 cycles. A total of 35 patients with advanced metastatic HRPC will be enrolled in this trial.
- Conditions
- Prostate Cancer
- Being tested
- azacitidine for injectable suspension
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azacitidine for injectable suspensionDrug
Also called Vidaza™
Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | azacitidine for injectable suspension Receives: Drug: azacitidine for injectable suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With PSA Doubling Time >=3 Months.
To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time >3= months.
Measured: Until progression or up to a maximum of 12 cycles
Secondary outcomes (5)
PSA Response Rate
Complete PSA Response defined as complete normalization of PSA maintained for at least 4 weeks, and partial PSA response defined as a decrease in PSA level of at least 50% from baseline level maintained for at least 4 weeks.
Measured: Every 8 weeks for 1 year.
Objective Response Rate by Recist (ORR)
ORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Measured: Every 8 weeks for 1 year.
Progression-free Survival
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 1.5 year.
1-year Overall Survival (OS)
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Measured: Up to 1 year.
Changes in Fetal Hemoglobin (HbF) With Time.
Time from baseline to maximal fetal hemoglobin (HbF).
Measured: Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2009
- Study completionNov 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 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Guru Sonpavde, MD, Principal investigator, US Oncology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384839
- Sponsor's protocol ID
- 05015
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2006
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy
- ClinicalTrials.gov ID
- NCT00384839
- Acronym / sponsor ID
- 05015
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation, University of Southern California
- Study start
- Apr 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Posted 25 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.
Detailed description
This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days (Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be evaluated prior to each cycle and % fetal hemoglobin will be evaluated prior to each odd cycle (excluding Cycle 1). Patients will be treated until clinical progression up to a maximum of 12 cycles. A total of 35 patients with advanced metastatic HRPC will be enrolled in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: azacitidine for injectable suspensionazacitidine for injectable suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A diagnosis of histologically confirmed, progressive, advanced metastatic, or nonmetastatic prostate cancer with documented PSA progression, with a calculated PSA doubling time <3 months, on complete androgen ablation therapy. PSA progression, with or without clinical progression (symptomatic/radiologic as per RECIST) is required; measurable disease is not required.
- Baseline PSA values must be followed by 2 serial increases at least 2 weeks apart (no upper limit for time for these 2 samples). Calculated PSA doubling time, for the above PSA values must be <3 months. An automated PSA doubling time calculator may be found at www.mskcc.org/mskcc/html/10088.cfm (see study tools).
- Currently on complete androgen ablation hormone therapy (an LHRH agonist plus an antiandrogen) with testosterone level <50ng/dL). Patients who are on LHRH agonist or other antiandrogenic therapy at entry will continue that therapy while on this study. Anti-androgen withdrawal is not necessary and is precluded before enrollment on the trial. The details of that therapy must be recorded in the CRF. Patients who have had an orchiectomy and who are on antiandrogen therapy are permitted on study.
- An elevated PSA level for patients progressing by PSA criteria is required (see protocol for specific detail).
- Has a Karnofsky Performance Status >70
Key exclusion criteria (14 listed)
- Has only clinical progression without evidence of PSA progression
- Has received prior chemotherapy
- Has had prior treatment with Vidaza
- Has a history of hypersensitivity to any component of Vidaza (mannitol)
- Has a history of New York Heart Association (NYHA) heart disease Class III or IV (Appendix III) or myocardial infarction within 6 months prior to Day 1 or unstable arrhythmia or evidence of ischemia on electrocardiogram (ECG)
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 |
|---|---|---|
| azacitidine for injectable suspensionAlso: Vidaza™Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles. | Drug | 1 |
Primary outcome
Percentage of Patients With PSA Doubling Time >=3 Months.
Time frame: Until progression or up to a maximum of 12 cycles
To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time >3= months.
5 secondary outcomes
PSA Response Rate
Time frame: Every 8 weeks for 1 year.
Objective Response Rate by Recist (ORR)
Time frame: Every 8 weeks for 1 year.
Progression-free Survival
Time frame: Up to 1.5 year.
1-year Overall Survival (OS)
Time frame: Up to 1 year.
Changes in Fetal Hemoglobin (HbF) With Time.
Time frame: Up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- 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.
Guru Sonpavde, MD principal investigator
US Oncology Research
13 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 azacitidine for injectable suspension in people with Prostate Cancer, run by US Oncology Research at 13 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 10 inclusion and 14 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 25 Oct 2018). 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?
Percentage of Patients With PSA Doubling Time >=3 Months. (time frame: Until progression or up to a maximum of 12 cycles). 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 25 Oct 2018.