Study of Sorafenib and Docetaxel in Metastatic Prostate Cancer
NCT ID: NCT00619996
Last Updated: 2009-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2007-03-31
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
However the prognosis of these patients remains very poor and new effective tolerated approaches are needed to improve the results of chemotherapy.
Rationale In a recent study a Raf kinase inhibitor protein (RKIP) encoded by a suppressor gene was found to be responsible of the metastatic process; in fact the decreased RKIP expression was associated with increased invasive capability of prostate cancer cells, presumably though the activation of MEK and ERK by phosphorilation .
Sorafenib, a novel signal transduction inhibitor, prevents tumor cell proliferation and angiogenesis blocking Raf/Mek/Erk pathway at the level of Raf kinase and tyrosine kinase receptors VEGFR-2 and PDGFR.
In a phase I study the combination of docetaxel and Sorafenib was evaluated in prostate and other tumors . The treatment was well tolerated and one partial response (4%) and 12 stable disease (50%) were reported.
According to these data we designed a phase II study to evaluate the association of Sorafenib and Docetaxel in metastatic prostate cancer
Simon's Optimal two-stage design for phase II clinical trial will be applied to calculate the sample size that minimizes the expected number of patients to be accrued. The sample size will be calculated on the following assumptions: alpha error =0.05, beta error =0.20; PD (clinically uninteresting true no progressive disease rate) and P1 (sufficiently promising true no progressive disease rate) will be set at 60% and 80%. 11 patients will be enrolled in the first stage: if no progressive diseases are \< 7 the accrual will be stopped and the drug's combination rejected. In the case of \>= 7 no progressive diseases 32 more patients will be accrued at the second stage. The treatment will be accepted if \>= 30 no progressive diseases out of 43 patients will be observed
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Sorafenib (Nexavar)
Sorafenib 400 mg bid orally continuously
Sorafenib will be administered from the start of treatment in combination with Docetaxel until progression of disease.
Docetaxel
Docetaxel 75 mg/mq ev g1 every 21 days. Docetaxel will be administered for a maximum of 9 cycles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sorafenib (Nexavar)
Sorafenib 400 mg bid orally continuously
Sorafenib will be administered from the start of treatment in combination with Docetaxel until progression of disease.
Docetaxel
Docetaxel 75 mg/mq ev g1 every 21 days. Docetaxel will be administered for a maximum of 9 cycles.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Italian Trial in Medical Oncology
OTHER
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dipartimento di Oncologia, dei Trapianti e delle Nuove Tecnologie in Medicina ... Indirizzo: via Roma, 55 - 56100 Pisa Tel. 050-2218690 - Fax. 050-2218685
Pisa, Pisa, Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PISAUNO
Identifier Type: -
Identifier Source: org_study_id