Hormone Refractory Prostate CancerPhase 2NCT00795171
Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
A Phase 2 study testing Docetaxel * Sunitinib and Docetaxel in people with Hormone Refractory Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer
- What is being tested?
- Docetaxel * Sunitinib and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2008to Jul 2011
- 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
- WHO performance status of 0-2.
- Histologically proven prostate adenocarcinoma.
- All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression
- Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:
- 25% increase in bidimensionally measurable soft tissue metastases
- Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)
- PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
- If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization
Who cannot join
- prior chemotherapy for prostate cancer
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Dept of Internal Medicine
Vienna, 1090
Volker VW Wacheck, MD, +43 1 40400 ext. 2989, Volker.Wacheck@meduniwien.ac.at
Michael, MK Krainer, MD
About this study
Official title: Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients
Read the detailed description
Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease.
We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.
- Conditions
- Hormone Refractory Prostate Cancer
- Being tested
- Docetaxel * Sunitinib, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel * SunitinibDrug
Also called Taxotere + Sutent
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
DocetaxelDrug
Also called Taxotere
docetaxel 75mg/m2 day1 q 21d x 4 cycles
DocetaxelDrug
Also called Taxotere
Docetaxel 75mg/m2 q21d for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + Sunitinib | Experimental | docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles Receives: Drug: Docetaxel * Sunitinib |
| Taxotere | Active comparator | docetaxel 75mg/m2 day1 q 21d x 4 cycles Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
Measured: 12 weeks
Secondary outcomes (1)
Response rate and length of treatment holidays relative to docetaxel monotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Refractory Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Michael MK Krainer, MD, Principal investigator, Dept of Internal Medicine I, Medical University Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795171
- Sponsor's protocol ID
- MK URO 4
- Other IDs
- EUDRACT 2007-003705-27
- Status last verified
- Aug 2010
- First submitted
- 20 Nov 2008
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
- ClinicalTrials.gov ID
- NCT00795171
- Acronym / sponsor ID
- MK URO 4
- Conditions
- Hormone Refractory Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 21 Nov 2008 (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.
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients
Detailed description
Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease.
We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + Sunitinib | Experimental | Drug: Docetaxel * Sunitinibdocetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles |
| Taxotere | Active comparator | Drug: Docetaxeldocetaxel 75mg/m2 day1 q 21d x 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- WHO performance status of 0-2.
- Histologically proven prostate adenocarcinoma.
- All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression
- Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:
- If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization
Key exclusion criteria (1 listed)
- prior chemotherapy for prostate cancer
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 |
|---|---|---|
| Docetaxel * SunitinibAlso: Taxotere + Sutentdocetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles | Drug | Docetaxel + Sunitinib |
| DocetaxelAlso: Taxoteredocetaxel 75mg/m2 day1 q 21d x 4 cycles | Drug | Taxotere |
| DocetaxelAlso: TaxotereDocetaxel 75mg/m2 q21d for 4 cycles | Drug | Taxotere |
Primary outcome
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
Time frame: 12 weeks
1 secondary outcome
Response rate and length of treatment holidays relative to docetaxel monotherapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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.
Michael MK Krainer, MD principal investigator
Dept of Internal Medicine I, Medical University Vienna, Austria
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 Docetaxel * Sunitinib and Docetaxel in people with Hormone Refractory Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Aug 2010. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael MK Krainer, MD (+43 1 40400 ext. 4445, michael.krainer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy (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 18 Aug 2010.