Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02560337
• Date of registration: 23/09/2015
• Prospective Registration: No
• Primary sponsor: Vejle Hospital
• Public title: Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy. CaTo-ROC
• Scientific title: Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase II Trial
• Date of first enrolment: September 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02560337
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Karina D Steffensen
• Affiliation: Vejle Hospital, Department of Oncology

Key inclusion & exclusion 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 status 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

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)

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: Cabazitaxel

Primary Outcome(s)

Number of patients alive and without progression after three months of treatment [Time Frame: 3 months after start of treatment]

Secondary Outcome(s)

Progression free survival [Time Frame: Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months]

Response rate [Time Frame: Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months]

Overall survival [Time Frame: Every three months up to 24 months]

Secondary ID(s)

CaTo-ROC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors