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Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial

Inclusion Criteria:

- Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
Stages I-IV.

- Patients with refractory disease defined as progression or no change during primary
treatment, as evaluated after 3 and/or 6 cycles of platinum/paclitaxel. Prior to
inclusion, patients must have received platinum and paclitaxel as combination

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or
evaluable by Gynecologic Cancer Interest Group (GCIG) cancer antigen 125 (CA-125)

- Age ≥ 18 years.

- Performance stage 0-2.

- Adequate bone marrow function, liver function, renal function, and coagulation
parameters (within 7 days prior to inclusion):

1. Neutrophils (ANC) ≥ 1.5 x 10^9/l

2. Platelet count ≥ 100 x 10^9/l

3. Serum bilirubin ≤ 1.0 x upper limit of normal (ULN)

4. Serum transaminase ≤ 2.5 x ULN

5. Serum creatinine ≤ 1.5 ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance
will be calculated according to the Chronic Kidney Disease Epidemiology
Collaboration formula (CKD-EPI)and patients with creatinine clearance <60 mL/min
should be excluded

- 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

- Concurrent or planned treatment with strong inhibitors or strong inducers of
cytochrome P4503A4/5 (a one 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 with disulfiram (antabuse)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of response to cabazitaxel

Outcome Description:

Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan

Outcome Time Frame:

Every 9 weeks up to two years

Safety Issue:


Principal Investigator

Anders Jakobsen, DMSc

Investigator Role:

Study Chair

Investigator Affiliation:

Vejle Hospital


Denmark: Danish Health and Medicines Authority

Study ID:




Start Date:

January 2013

Completion Date:

October 2015

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer
  • Platinum refractory
  • Ovarian Neoplasms