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Study of Sorafenib and Docetaxel in Metastatic Prostate Cancer (P1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00619996
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 26, 2009
Information provided by:
Italian Trial in Medical Oncology

Brief Summary:
The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics (PD) in Patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Sorafenib (Nexavar) Drug: Docetaxel Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sorafenib (Bay 43-9006) and Docetaxel in Metastatic Prostate Cancer
Study Start Date : March 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1 Drug: 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.


Drug: Docetaxel
Docetaxel 75 mg/mq ev g1 every 21 days. Docetaxel will be administered for a maximum of 9 cycles.

Primary Outcome Measures :
  1. N° of no progressive disease [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with metastatic hormone refractory prostate cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00619996

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Dipartimento di Oncologia, dei Trapianti e delle Nuove Tecnologie in Medicina ... Indirizzo: via Roma, 55 - 56100 Pisa Tel. 050-2218690 - Fax. 050-2218685
Pisa, Italy, 56100
Sponsors and Collaborators
Italian Trial in Medical Oncology

Layout table for additonal information Identifier: NCT00619996     History of Changes
Other Study ID Numbers: PISAUNO
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009
Keywords provided by Italian Trial in Medical Oncology:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors