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

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00405210
First received: November 28, 2006
Last updated: May 20, 2011
Last verified: May 2011

November 28, 2006
May 20, 2011
September 2006
August 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT00405210 on ClinicalTrials.gov Archive Site
  • Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel* [ Time Frame: after the first 24 patients ] [ Designated as safety issue: Yes ]
  • Toxicity and safety [ Time Frame: at end of study ] [ Designated as safety issue: Yes ]
  • Response rate in patients with measurable disease [ Time Frame: at end of study ] [ Designated as safety issue: Yes ]
  • PSA response rate [ Time Frame: at end of study ] [ Designated as safety issue: Yes ]
  • PSA response duration [ Time Frame: at end of study ] [ Designated as safety issue: No ]
  • Time to PSA progression (=time between treatment start and PSA progression) [ Time Frame: at end of study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Event progression-free survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
  • Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel*
  • Toxicity and safety
  • Response rate in patients with measurable disease
  • PSA response rate
  • PSA response duration
  • Time to PSA progression (=time between treatment start and PSA progression)
  • 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)
  • Event progression-free survival
Not Provided
Not Provided
 
Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer
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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Disease
  • Prostate Cancer
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
Other Name: Nexavar
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2009
August 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT00405210
UCL-ONCO 06-003, BAY 43-9006/12180
No
Cliniques universitaires Saint-Luc-Université Catholique de Louvain, Prof. J-P Machiels
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
Study Director: Jean-Pascal H Machiels, Prof Cliniques Universitaires St Luc -UCL
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP