Cabazitaxel in patients with Recurrent Ovarian Cancer after failure of standard therapy. A phase 2, open-label study

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 34

Inclusion Criteria

•Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
•Platinum resistant ovarian cancer with at least two previous cytostatic regimens or platinum-refractory disease defined as progression while receiving the last line of platinum based therapy or within 4 weeks of last platinum dose
•Progression on previous treatment.
•Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria
•Age = 18 years.
•Performance stage 0-2.
•Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- Neutrophils (ANC) = 1.5 * 10^9/l
- Platelet count = 100 * 10^9/l
- Hemoglobin = 9.0 g/dL or = 5.6 mmol/l
- Serum bilirubin = 1.0 * ULN
- Serum transaminase = 2.5 * ULN
- Serum creatinine = 1.5 ULN (at creatinine above 1.5 x ULN measured GFR must be at least 50 ml / min)
•Remaining life expectancy of at least 3 months
•Written informed consent

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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

•History of severe hypersensitivity reaction (=grade 3) to taxol.
•History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs.
•Allergy to the active substance or any of the auxiliary agents.
•Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week wash-out period is necessary for patients who are already on these treatments) (see Appendix).
•Neuropathy grade = 2.
•Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
•Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
•Other malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
•Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
•History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
•Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.

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

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