Prostate CancerPhase 2NCT00027781
MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
A Phase 2 study testing sabarubicin in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 6 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy. 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?
- sabarubicin
- How many people
- 37 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Aug 2001to Mar 2003
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed hormone-refractory adenocarcinoma of the prostate
- Disease progression while on prior luteinizing hormone-releasing hormone (LHRH) analogues or after orchiectomy and antiandrogens, given concurrently or consecutively
- Disease progression is defined as PSA progression documented by increases in PSA recorded at 2 consecutive measurements over a prior reference value
- Interval of at least 1 week between the reference value and the first of these two PSA increases
- Continued elevation of PSA for at least 6 weeks after discontinuation of antiandrogens
- Last PSA value at least 5 ng/mL (Hybritech equivalent)
- Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist therapy if no prior surgical castration
- No symptomatic brain or leptomeningeal metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.7 mg/dL
- No uncontrolled hypercalcemia
Cardiovascular:
- No history of severe heart disease
- No myocardial infarction within the past 6 months
- No cardiac insufficiency
- Normal cardiac function by MUGA scan and 12-lead EKG
Other:
- No other prior or concurrent malignancy except basal cell or squamous cell skin cancer
- No uncontrolled systemic nonmalignant disease or infection
- No psychological, familial, or geographical conditions that would preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No prior hormonal therapy except estramustine
- No concurrent estramustine
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy (e.g., for painful bone metastases)
Surgery:
- See Disease Characteristics
Other:
- No other concurrent experimental drugs or investigational therapy
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
France5 sites
Institut Bergonie
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, 21079
CHU de la Timone
Marseille, 13385
CHU Pitie-Salpetriere
Paris, 75651
About this study
Official title: Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES:
- Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate.
- Determine the rate and duration of objective PSA response in patients treated with this drug.
- Determine the clinical response rate in patients with measurable disease treated with this drug.
- Determine the acute side effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Beginning within 2 weeks after the last PSA measurement, patients receive MEN-10755 IV over 30 minutes on day 1. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response continue to receive additional courses. Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator.
Patients are followed every 6 weeks until disease progression or initiation of a new therapy.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- sabarubicin
- Keywords
- adenocarcinoma of the prostate, recurrent 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.
sabarubicinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2001
- Primary completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Walter Fiedler, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027781
- Sponsor's protocol ID
- EORTC-16006-30005
- Other IDs
- EORTC-16006-30005, MAC-07
- Status last verified
- Jul 2012
- First submitted
- 7 Dec 2001
- Last updated
- 24 Jul 2012
- Results posted
- No
Publications
Fiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. doi: 10.1016/j.ejca.2005.07.030. Epub 2005 Dec 7.
PubMed 16337787
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00027781
- Acronym / sponsor ID
- EORTC-16006-30005
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Aug 2001
- Primary completion
- Mar 2003 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES:
- Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate.
- Determine the rate and duration of objective PSA response in patients treated with this drug.
- Determine the clinical response rate in patients with measurable disease treated with this drug.
- Determine the acute side effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Beginning within 2 weeks after the last PSA measurement, patients receive MEN-10755 IV over 30 minutes on day 1. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response continue to receive additional courses. Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator.
Patients are followed every 6 weeks until disease progression or initiation of a new therapy.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sabarubicin | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jul 2012.
- Results publication: PubMed 16337787Fiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. doi: 10.1016/j.ejca.2005.07.030. Epub 2005 Dec 7.
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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.
Walter Fiedler, MD study chair
Universitätsklinikum Hamburg-Eppendorf
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sabarubicin in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium, Germany, Israel, Spain and 1 more country. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027781, which also lists 1 linked publication.
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 24 Jul 2012.