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Cabazitaxel in Platinum Refractory Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01747239
Recruitment Status : Terminated (Too low inclusion rate. Only 4 patients included over 16 months)
First Posted : December 11, 2012
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:

Ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. This constitutes a major therapeutic problem and new treatment approaches are highly needed.

Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has effect in patients refractory to taxotere. Consequently, it could be anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Cabazitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial
Study Start Date : January 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Cabazitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cabazitaxel
25 mg/m2 IV every three weeks
Drug: Cabazitaxel
25 mg/m2 IV every three weeks

Primary Outcome Measures :
  1. Rate of response to cabazitaxel [ Time Frame: Every 9 weeks up to two years ]
    Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Every three months until progression or death, up to three years ]
  2. Overall survival [ Time Frame: Every 3 months up to three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 treatment.
  • 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) criteria.
  • 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 drugs.
  • 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.
  • Treatment with disulfiram (antabuse)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747239

Department of Oncology, Aalborg Hospital
Aalborg, Denmark, DK-9100
Herlev Hospital
Herlev, Denmark
Department of Oncology, Odense University Hospital
Odense, Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Study Chair: Anders Jakobsen, DMSc Vejle Hospital
Principal Investigator: Christine V Madsen, MD Vejle Hospital

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01747239     History of Changes
Other Study ID Numbers: TaxOvar
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Vejle Hospital:
Ovarian cancer
Platinum refractory

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders