Study of Sorafenib and Docetaxel in Metastatic Prostate Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	February 11, 2008
Last Updated Date	February 25, 2009
Start Date ^ICMJE	March 2007
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 25, 2009)	N° of no progressive disease [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: February 20, 2008)	N° of no progressive disease [ Time Frame: evaluated by PSA ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00619996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 25, 2009)	ORR,Duration of responses,TTP,OS,PSA doubling time, PK-PD,of Sorafenib plus docetaxel,Baseline pERK concentration, phospho VEGF-R2 concentration, plasma proteomics and gene expression profiling on blood cells and tumor biopsy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: February 20, 2008)	ORR,Duration of responses,TTP,OS,PSA doubling time, PK-PD,of Bay plus docetaxel,Baseline pERK concentration, phospho VEGF-R2 concentration, plasma proteomics and gene expression profiling on blood cells and tumor biopsy. [ Time Frame: Recist Criteria ] [ Designated as safety issue: Yes ]

Descriptive Information
Brief Title ^ICMJE	Study of Sorafenib and Docetaxel in Metastatic Prostate Cancer
Official Title ^ICMJE	Phase II Study of Sorafenib (Bay 43-9006) and Docetaxel in Metastatic Prostate Cancer
Brief Summary	The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics (PD) in Patients with prostate cancer.
Detailed Description	Background Prostate cancer is the most common malignancy in men and the second leading cause of cancer death among males in the Western World. When tumors become refractory to androgen withdrawal therapy, chemotherapy represent a palliative treatment with an improvement on quality of life, particularly the combination of mitoxantrone and prednisone . This observation has led to numerous studies evaluating the potential use of new chemotherapeutic agents as Docetaxel in patients with metastatic androgen independent prostate cancer. Recently Docetaxel based regimens have shown an improvement in survival when compared with mitoxantrone in a phase III trial . 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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: Sorafenib (Nexavar) Drug: Docetaxel
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	43
Completion Date	January 2009
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with metastatic hormone refractory prostate cancer
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT ID ^ICMJE	NCT00619996
Responsible Party
Study ID Numbers ^ICMJE	PISAUNO
Study Sponsor ^ICMJE	Italian Trial in Medical Oncology
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Italian Trial in Medical Oncology
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP