Cabazitaxel in ovarian cancer patients who do not respond to platinum-based chemotherapy. A phase II trial

• Conditions: Platinum refractory ovarian cancer; MedDRA version: 14.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001224-35-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 < 40 mL/min should be excluded.
•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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified