Status:
COMPLETED
Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Primary Disease
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 du...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00405210
Start Date
September 1 2006
End Date
December 1 2009
Last Update
May 23 2011
Active Locations (6)
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1
St Pierre
Ottignies, Brabant Wallon, Belgium, 1340
2
Cliniques Universitaires St Luc
Brussels, Brussels Capital, Belgium, 1200
3
Notre Dame et Reine Fabiola
Charleroi, Hainaut, Belgium, 6000
4
Sainte Elisabeth
Namur, Namur, Belgium, 5000