Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer

NCT ID: NCT00405210

Last Updated: 2011-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-12-31

Brief Summary

The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated to taxotere for first-line treatment of patient with prostatic cancer.

BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is orally available and has a favorable safety profile in patients with advanced solid tumors. This, together with the antitumor activity observed after treatment with BAY 43-9006 (SORAFENIB), provides a rationale for further evaluation in patients with advanced cancer. The recommended dose of BAY 43-9006 (SORAFENIB) for future studies is 400 mg bid as a continuous dosing schedule.

Detailed Description

This study propose to treat patients with metastatic and hormone-refractory prostatic cancer in first intention. There is no limits of age from 18 years old. A new inhibitor of angiogenesis (Sorafenib) is associated to the standard treatment in this type of pathology.

Patients have to demonstrate radiologically a disease progression and also a progression based on increase of psa level.

The main objective is to Determine the recommended dose of BAY 43-9006 in combination with docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients with metastatic hormone-refractory prostate cancer.

Conditions

Primary Disease; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sorafenib (200 or 400mg bid) and taxotere iv

200 mg BID, day 3-19 cycle 1, day 2-19 other cycles 200 mg BID, day 3-21 Cycle 1, day 1-21 other cycles 400 mg BID, day 3-19 cycle 1, day 2-19 other cycles 400 mg BID, day 3-21 cycle 1, day 1-21 other cycles

Intervention Type: DRUG

Other Intervention Names

Nexavar

Eligibility Criteria

Inclusion Criteria

• Signed informed consent prior to beginning protocol specific procedures.
• 18 years
• Radiologically proven presence of metastases
• Histologically/cytologically proven prostate adenocarcinoma.
• Biochemically evaluable disease
• Patients must have received prior hormonal therapy as defined below:

• Castration by orchiectomy and/or LHRH agonists with or without
• Antiandrogens
• Other hormonal agents (e.g., ketoconazole, ...)
• The testosterone level should be < 50 ng/dl (10) documented disease progression defined by PSA increase. Patients must have a value of at least 5 ng/ml in addition to increasing PSA to be eligible.
• Life expectancy > 3 months
• ECOG performance status 0-2.
• Normal cardiac function.

Exclusion Criteria

• Prior chemotherapy except estramustine phosphate.
• Prior isotope therapy (e.g., strontium, samarium).
• Prior radiotherapy to >25% of bone marrow
• Prior therapy with anti-VEGF therapy
• Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
• History or presence of central nervous system (CNS) disease (i.e. primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
• Symptomatic peripheral neuropathy
• Other serious illness or medical condition the use of corticosteroids.
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BAY 9006.
• Major surgery with 4 weeks of study entry
• Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
• Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry
• Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped.
• Treatment with drugs that are metabolized by the cytochrome P450 system (i.e warfarin sodium,…)
• Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped.
• Biphosphonates could not be initiated after inclusion into the protocol. At inclusion, patients receiving biphosphonates with a PSA progression could continue biphosphonates.
• Patients with reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial.
• Inadequate recovery from previous surgery, radiation, chemo-, biologic or immunotherapy
• Patients who have known hypersensitivity to the study medication
• Substance abuse, medical social, psychological conditions that may interfere with the subject's participation in the study or evaluation of study results
• Patients unable to sallow oral medications.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Prof. J-P Machiels

Principal Investigators

Jean-Pascal H Machiels, Prof

Role: STUDY_DIRECTOR

Cliniques Universitaires St Luc -UCL

Locations

St Pierre

Ottignies, Brabant Wallon, Belgium

Cliniques Universitaires St Luc

Brussels, Brussels Capital, Belgium

Notre Dame et Reine Fabiola

Charleroi, Hainaut, Belgium

Sainte Elisabeth

Namur, Namur, Belgium

Clinique Universiataire de Mont Godinne

Yvoir, Namur, Belgium

Hôpital Européen Georges Pompidou

Paris, , France

Countries

Belgium; France

Other Identifiers

BAY 43-9006/12180

Identifier Type: -

Identifier Source: secondary_id

UCL-ONCO 06-003

Identifier Type: -

Identifier Source: org_study_id