Cabazitaxel and Abiraterone Acetate in Patients with Metastatic Castrate-Resistant Prostate Cancer
- Conditions
- prostate cancerMedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001506-96-GB
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 37
Diagnosis of prostate adenocarcinoma proven histologically or cytologically, resistant to hormone therapy and previously treated with a docetaxel-containing regimen. In Phase 2 part, patients should have been treated with ABIa for at least 3 months and should continue treatment with ABIa before study entry.
Presence of metastatic prostate cancer. Patient must have progressive disease documented by rising PSA defined as 2 sequential increases above a previous lowest reference value (each PSA value must be obtained at least 1 week apart. A PSA value of at least 6 ng/mL is required at study entry). In Phase 1 part, in addition to rising PSA, progressive disease must be documented by:
a) Increase in non-measureable disease or measurable disease, and/or
b) Appearance of new lesions, including those on bone scan (=2 new lesions on 2 consecutive bone scans if progressive disease diagnosed on bone scan only) consistent with progressive prostate cancerEffective castration (serum testosterone levels =0.50 ng/mL) by orchiectomy and/or luteinizing hormone releasing hormone agonists /antagonist.
a) If the patient has been treated with luteinizing hormone-releasing hormone agonists/antagonist (i.e., without orchiectomy), then this therapy must have been initiated at least 4 weeks prior to cycle 1 day 1 and should be continued throughout the study.
b) Prior anti-androgen therapy should be stopped before enrollment Eastern Cooperative Oncology Group performance status: 0 – 1
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 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27
Previous treatment with mitoxantrone or CBZ.
Prior bone-seeking radio-isotope therapy (patients treated with Radium223 are not excluded from the study). Radiotherapy to =30% of bone marrow.
Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria v4.03) at the time of enrollment.
Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study (except luteinizing hormone-releasing hormone agonist /antagonist and ABIa in the Phase 2 part of the study); small field single fraction palliative radiation within 1 week.
Prior malignancy. Curatively treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed = 3 years ago and from which the patient has been disease-free for = 3 years.
Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to enrollment.
Known brain or leptomeningeal metastases.
Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or to comply with the study procedures or interfere with interpretation of study results to the study
Other concurrent serious illness or medical conditions
Absence of signed and dated Institutional Review Board -approved patient informed consent form prior to enrollment into the study.
History of hypersensitivity to docetaxel, polysorbate 80
Known allergies, hypersensitivity or intolerance to prednisone or excipients of abiraterone acetate
Known history of mineralocorticoid excess or deficiency
Inadequate organ and bone marrow function and biochemical indices as evidenced by:
a) Hemoglobin <10.0 g/dL
b) Absolute neutrophil count <1.5 x 10^9/L
c) History of primary G-CSF prophylactics required for prior chemotherapy
d) Platelet count < 100 x 10^9/L
e) Potassium <3.5 mmol/L
f) AST/SGOT and/or ALT/SGPT > 2.5 x the institutions upper limit of normal
g) Total bilirubin > 1.0 x the institutions upper limit of normal
h) Serum albumin < 3.0 g/dL
i) Child-Pugh class B&C
j) Serum Creatinine > 1.5 x the institutions upper limit of normal. If creatinine 1.0 - 1.5 x the institutions upper limit of normal, creatinine clearance will be calculated; Creatinine clearance < 60 mL/min/1.73m2 will exclude the patient
Contraindications to the use of corticosteroid treatment.
Symptomatic peripheral neuropathy grade > 1
Concurrent treatment with strong inducers or strong inhibitors of cytochrome P450 3A4, or patients planning to receive these treatments
Concurrent treatment with medications metabolized by CYP2D6, particularly for those with a small therapeutic window
History of cardiac arrhythmias requiring medical therapy such as atrial fibrillation requiring anticoagulation or digoxin/digitalis; uncontroll
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method