Status:
COMPLETED
Study of Weekly Cabazitaxel for Advanced Prostate Cancer
Lead Sponsor:
Spanish Oncology Genito-Urinary Group
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel. The purpos...
Detailed Description
The efficacy of three-weekly cabazitaxel is accompanied by an appreciable rate of serious side effects and toxic deaths. The toxicity rates observed, including grade III-IV neutropenia, febrile neutro...
Eligibility Criteria
Inclusion
- Patients who have given written informed consent.
- Age ≥ 18 years.
- ECOG 0-2.
- Patients with a histologic or cytologic diagnosis of advanced prostate cancer (any Gleason grade).
- Previous and ongoing castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start.
- Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2.
- "Unfit" patients defined as patients who satisfy at least one of the following criteria:
- ECOG 2
- Dose reduction due to febrile neutropenia during the previous treatment with docetaxel
- Radiation therapy affecting more than 25% of bone marrow reserve
- Documented metastatic disease and progressing after docetaxel treatment. Progression criteria is considered any of the following three or more than one at once:
- Progressive elevation of PSA measured in three successive determinations one week difference between them at least;
- Should be considered progression of measurable disease by RECIST criteria;
- Bone progression as evidenced by the appearance of two or more new lesions on bone scan.
- Patients who have received a maximum of one prior chemotherapy for metastatic disease.
- Prior anticancer therapy should have been interrupted 28 days before the start of study treatment (the patient may have continued treatment with prednisone 5 mg bid.
- Adequate blood, liver and kidney function:
- Hemoglobin \> 9.0 g/dl
- ANC \> 1.5 x 10\*9/L
- Platelets \> 100 x 10\*9/L
- AST/SGOT and ALT/SGPT \< 2.5 x ULN
- Bilirubin \< 1.0 x ULN
- Creatinine \<1.5 mg/dL x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded (see Annex 7 for formula)
- Adequate baseline cardiac function (LVEF ≥ 50%).
- Life expectancy ≥ 12 weeks.
- Patients must agree to use an effective contraceptive method during treatment with the study drug and up to 1 month after ending the treatment.
Exclusion
- Patients who received radiation therapy that exceeded 40% of the bone marrow reserve or that ended within the last 3 weeks prior to inclusion.
- If being treated with radiation therapy, should be completed before the three weeks prior to initiation of treatment research.
- Previous treatment with two or more chemotherapy regimens for metastatic disease. A new line of treatment is also when a patient receives again docetaxel after clinical, radiological or PSA progression to a prior regimen with docetaxel.
- Previous treatment with chemotherapy or surgery in the last 4 weeks.
- Peripheral neuropathy or stomatitis ≥ 2 (National Cancer Institute Common Terminology Criteria - NCI CTCAE vs. 4.03).
- Any other type of cancer in the last 5 years, except for basal cell skin carcinoma.
- Cerebral or leptomeningeal metastasis.
- Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass, congestive heart failure (NYHA class III or IV), stroke or transitory ischemic episodes.
- Patients who present any severe or uncontrolled medical condition (including uncontrolled diabetes mellitus) or any other condition that may affect the patient's participation and study compliance.
- Previous treatment with cabazitaxel.
- Known hypersensitivity (≥ grade 3)to cabazitaxel, polysorbate 80, prednisone or prednisolone, or docetaxel or paclitaxel.
- Known history of active infection that requires systemic antibiotic or antifungal treatment.
- Patients who are receiving or expect to receive treatment with strong inhibitors or strong inducers of cytochrome CYP450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annexes 5 and 6).
- Patients being treated with any investigational product.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01518283
Start Date
May 1 2012
End Date
July 1 2016
Last Update
July 2 2017
Active Locations (12)
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1
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Institut Català D'Oncologia L'Hospitalet (Ico)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
3
Hospital de Sant Joan de Déu
Manresa, Barcelona, Spain, 08243
4
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922