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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Docetaxel; Sorafenib

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.