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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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
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
Determine the recommended dose of BAY 43-9006 (SORAFENIB) in combination with docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients with metastatic hormone refractory prostate cancer.
Time frame: after the first 24 patients
Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel*
Time frame: after the first 24 patients
Toxicity and safety
Time frame: at end of study
Response rate in patients with measurable disease
Time frame: at end of study
PSA response rate
Time frame: at end of study
PSA response duration
Time frame: at end of study
Time to PSA progression (=time between treatment start and PSA progression)
Time frame: at end of study
Time to PSA progression after the last dose of docetaxel in patients with no progression after stopping docetaxel (= time between the last dose of docetaxel and PSA progression)
Time frame: at end of study
Event progression-free survival
Time frame: at end of study
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