MedDRA version: 20.0 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: cabazitaxel
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: cabazitaxel
CAS Number: 183133-96-2
Other descriptive name: CABAZITAXEL
Concentrat
Sponsors
Vejle Hospital, Department of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the effect of cabazitaxel in patients with recurrent ovarian cancer.;Secondary Objective: Not applicable;Primary end point(s): • The fraction of patients alive and without progression after three months of treatment with cabazitaxel.;Timepoint(s) of evaluation of this end point: 3 months after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Progression free survival (PFS) and response rate (RR) before and after cross-over. 2) Overall survival (OS). 3) To investigate the potential toxicity of the treatment. 4) To investigate quality of life during the treatment (QLQ C30, C28). ;Timepoint(s) of evaluation of this end point: 1) Every 9 weeks until progression or death 2) After progression every 3 months until death 3) Every 3 weeks until progression 4) Every 9 weeks and 30 days after last treatment | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Vejle Hospital
Outcome results
None listed