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

Prostate Cancer Clinical Trial

Official title:

Open-label, Multicenter,PhaseI Trial in Order To Determine the Safety and Pharmacokinetics of BAY43-9006 in Combination With Docetaxel as First-line Treatment in Metastatic Hormone Refractory Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405210
• Other study ID #: UCL-ONCO 06-003
• Secondary ID: BAY 43-9006/1218
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2006
• Last updated: May 20, 2011
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2011
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Disease
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels	Brussels Capital
Belgium	Notre Dame et Reine Fabiola	Charleroi	Hainaut
Belgium	Sainte Elisabeth	Namur
Belgium	St Pierre	Ottignies	Brabant Wallon
Belgium	Clinique Universiataire de Mont Godinne	Yvoir	Namur
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		after the first 24 patients	Yes
Secondary	Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel*		after the first 24 patients	Yes
Secondary	Toxicity and safety		at end of study	Yes
Secondary	Response rate in patients with measurable disease		at end of study	Yes
Secondary	PSA response rate		at end of study	Yes
Secondary	PSA response duration		at end of study	No
Secondary	Time to PSA progression (=time between treatment start and PSA progression)		at end of study	No
Secondary	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)		at end of study	Yes
Secondary	Event progression-free survival		at end of study	No