Prostate CancerPhase 1/2NCT00132756
Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
A Phase 1/2 study testing Doxil and Estramustine in people with Prostate Cancer, run by Morton Plant Mease Health Care at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate cancer that is resistant to hormones and to a chemotherapy type called taxanes. 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?
- Doxil and Estramustine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to not given
- Phase
- Phase 1/2
- 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
- Patients must have histologically confirmed advanced, prostate cancer
- Patients must have evaluable disease that may be evaluated by PSA or measurement.
- Patients must be hormone refractory as defined in this protocol.
- Patients must be taxane refractory as defined in this protocol.
- Patients have had no prior chemotherapy other than a taxane or estramustine phosphate.
- Patients may have had prior radiation therapy (RT) if it has been >/= 4 weeks since completion.
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- Patients on bisphosphonates may be included.
- Patients must be at least 18 years of age or older.
- Patients must have the ability to speak and understand English.
- Patients must have an ECOG performance status of 2 or less.
- Patients must have adequate bone marrow function: platelets > 100,000 cells/mm3; hemoglobin > 9.0 g/dL; and absolute neutrophil count (ANC) > 1,000 cells/mm3.
- Patients must have adequate renal function: creatinine < 2.5 mg/dL.
- Patients must have adequate liver function.
- Ejection fraction of > 50% within 42 days of first dose of study drug.
- Ability to complete the McGill-Melzack Pain Intensity Scale.
Who cannot join
- Patients with unstable medical conditions such as liver, renal dysfunctions, blood clots or heart disease.
- History of hypersensitivity to doxorubicin.
- History of class II cardiac disease or evidence of congestive heart failure.
- RT within the past 4 weeks of study entry or a radiopharmaceutical within the past 8 weeks of study entry.
- Prior malignancy within the past 5 years except for non-melanotic skin cancers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Morton Plant Mease Health Care
Clearwater, Florida, 33756
About this study
Official title: Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate cancer that is resistant to hormones and to a chemotherapy type called taxanes.
The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA) level by at least 50% from baseline.
- Conditions
- Prostate Cancer
- Being tested
- Doxil and Estramustine
- Keywords
- Hormone Refractory, Taxane Refractory
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxil and EstramustineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the measurable disease and PSA level by at least 50%
Secondary outcomes (1)
To determine safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startDec 2003
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Morton Plant Mease Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech Products, L.P.
- Investigators
- Robert Drapkin, MD, Principal investigator, Morton Plant Mease Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132756
- Sponsor's protocol ID
- DO03-25-002
- Status last verified
- Nov 2006
- First submitted
- 18 Aug 2005
- Last updated
- 8 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00132756
- Acronym / sponsor ID
- DO03-25-002
- Conditions
- Prostate Cancer
- Keywords
- Hormone Refractory, Taxane Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Morton Plant Mease Health CareUniversity, hospital or other
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Dec 2003
- First posted
- 22 Aug 2005 (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.
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate cancer that is resistant to hormones and to a chemotherapy type called taxanes.
The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA) level by at least 50% from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically confirmed advanced, prostate cancer
- Patients must have evaluable disease that may be evaluated by PSA or measurement.
- Patients must be hormone refractory as defined in this protocol.
- Patients must be taxane refractory as defined in this protocol.
- Patients have had no prior chemotherapy other than a taxane or estramustine phosphate.
Key exclusion criteria (5 listed)
- Patients with unstable medical conditions such as liver, renal dysfunctions, blood clots or heart disease.
- History of hypersensitivity to doxorubicin.
- History of class II cardiac disease or evidence of congestive heart failure.
- RT within the past 4 weeks of study entry or a radiopharmaceutical within the past 8 weeks of study entry.
- Prior malignancy within the past 5 years except for non-melanotic skin cancers.
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 |
|---|---|---|
| Doxil and Estramustine | Drug | – |
Primary outcome
Reduce the measurable disease and PSA level by at least 50%
1 secondary outcome
To determine safety and tolerability
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2006.
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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.
Robert Drapkin, MD principal investigator
Morton Plant Mease Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Doxil and Estramustine in people with Prostate Cancer, run by Morton Plant Mease Health Care 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 15 inclusion and 5 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 8 Nov 2006. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Reduce the measurable disease and PSA level by at least 50%. 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 Nov 2006.