Platinum refractory ovarian cancer MedDRA version: 14.1 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Jevtana
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. • Patients with refractory disease defined as progression or no change during primary 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. If creatinine 1.0 - 1.5 x ULN, chrom-EDTA clearence will be investigated. Patients with creatinin clearence =65 years) yes F.1.3.1 Number of subjects for this age range 20
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. • 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. • CNS metastases not treated with radiotherapy. • 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. • Treatment with disulfiram (antabuse)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the response rate of cabazitaxel in platinum refractory, ovarian cancer. ;Secondary Objective: • To investigate the feasibility and safety of cabazitaxel treatment in ovarian cancer patients assessed by NCI CTCAE v.4.0. • To investigate progression free survival (PFS), overall survival (OS), and toxicity. ;Primary end point(s): • Response rate according to RECIST 1.1 or GCIG criteria.;Timepoint(s) of evaluation of this end point: every 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety and feasibility • Progression free survival (PFS) • Overall survival (OS) • Toxicity ;Timepoint(s) of evaluation of this end point: Safety, feasibility, and toxicity every 3 weeks Progression free survival every 9 weeks | — |
Countries
Denmark
Outcome results
None listed