Multi-center, randomized, double-blind phase II study of sorafenib or placebo with best supportive care after failure of deocetaxol in metastatic hormone-refractory prostate cancer
- Conditions
- metastatic hormone-refractory prostate cancerMedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer
- Registration Number
- EUCTR2007-002370-64-AT
- Lead Sponsor
- Austrian Prostate Study Group (AUPSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 50
1Age = 18 years
2Histologically / cytologically proven adenocarcinoma of the prostate
3Metastatic disease with documented clinical (imaging) progression of an existing lesion (RECIST), appearance of a new lesion, or bone scan showing new skeletal lesions following docetaxel application. Biochemical (PSA) progression alone is not sufficient to document progression.
4One prior chemotherapy with a total dose of 450 mg/m2 docetaxel.
5Prior surgery and/or radiation therapy (to less or equal than 25% of the bone marrow only) are allowed. At least 4 weeks must have elapsed since the completion of surgery/radiation therapy and the patient must have recovered from side-effects.
6Disease progression after prior hormonal therapy and subsequent cytotoxic chemotherapy with a total dose of 450mg/m2 docetaxel
7Patients should have progressive disease defined as PSA progression documented by 2 consecutive rises in PSA values over a previous reference value taken at least one week apart or measurable disease progression according to the modRECIST criteria.
8PSA at time of study entry = 5 ng/ml within 1 week prior to randomization.
9Castrate level of testosterone (? 0.5 ng/ml). Patients with medical castration with LH-RH analogue must continue LH-RH analogue.
10Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at least 6 weeks prior to the start of chemotherapy.
11Continuation of bisphosphonates allowed.
12ECOG PF 0-2
13Life expectancy > 12 weeks
14Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
•Hemoglobin > 9.0 g/dl
•Absolute neutrophil count (ANC) >1,500/mm3
•Platelet count = 100,000/µl
•Total bilirubin < 1.5 times the upper limit of normal (ULN)
•ALT and AST < 2.5 x ULN (< 5 ULN for patients with liver involvement)
•PT-INR/PTT < 1.5 x ULN (Patients who receive anticoagulation therapy with an agent will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
•Serum creatinine < 1.5 x ULN (in case of limit values of serum creatinine, creatinine clearance calculated by Cockroft-Gault method should be = 60 ml/min)
15Signed informed consent must be obtained prior to any study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
2History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
3History of HIV infection or chronic hepatitis B or C
4Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
5Clinically symptomatic brain or meningeal metastasis
6Patients with seizure disorder requiring medication (such as anti-epileptics)
7Evidence of painful and/or destructive bone metastases for which radiation therapy, initiation of bisphosphonates or bone-seeking radionucleides are considered necessary by the treating physician. Other bone metastases are allowed.
8History of organ allograft
9Patients with evidence or history of bleeding diasthesis
10Patients undergoing renal dialysis
11More than 1 prior anticancer chemotherapy or immunotherapy during or within 4 weeks of the study entry
12Prior isotope therapy (e.g. strontium, samarium)
13Radiotherapy during study or within 3 weeks of start of study drug
14Major surgery within 4 weeks of start of study
15Autologous bone marrow transplant or stem cell rescue within 4 months of study
16Investigational drug therapy outside of this trial during or within 4 weeks of study entry
17Prior exposure to the study drug or licensed angiogenesis-inhibitors.
18Prior use of inhibitors of Ras/Raf-, MEK, AKT kinase and mTOR-signaling pathway or farnesyl transferase inhibitors
19Concomitant treatment with ketoconazole, itraconazole, ritonavir, rifampicin.
20Childbearing potential: men enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
21Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
22Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
23Patients unable to swallow oral medications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the 12-week stabilization rate of sorafenib or placebo after docetaxel failur in patients with hormone-refractory prostate cancer.;Secondary Objective: To assess the response rate according to RECIST criteria<br>To assess progression free survival<br>To evaluate quality of life (QLQ-C30)<br>To measure markers of the in vivo anti-tumor efficacy and mechanisms of action (optional)<br>To measure cell signaling and tumor cell death in biopsies (optional);Primary end point(s): The stabilizazion of hormone-refractory prostate cancer in patients with docetaxol failure after 12 week treatment with sorafenib or placebo and best supportive care.
- Secondary Outcome Measures
Name Time Method