Cabazitaxel in Platinum Refractory Ovarian Cancer

This study is currently recruiting participants.
Verified March 2014 by Vejle Hospital
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01747239
First received: December 6, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: Cabazitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Rate of response to cabazitaxel [ Time Frame: Every 9 weeks up to two years ] [ Designated as safety issue: No ]
    Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Every three months until progression or death, up to three years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months up to three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel
25 mg/m2 IV every three weeks
Drug: Cabazitaxel
25 mg/m2 IV every three weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747239

Contacts
Contact: Anders Jakobsen, DMSc anders.jakobsen@rsyd.dk

Locations
Denmark
Department of Oncology, Aalborg Hospital Recruiting
Aalborg, Denmark, DK-9100
Principal Investigator: Bente Lund, MD         
Herlev Hospital Recruiting
Herlev, Denmark
Principal Investigator: Hanne Havsteen, MD         
Department of Oncology, Odense University Hospital Recruiting
Odense, Denmark
Principal Investigator: Bente Sorensen, MD         
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Anders Jakobsen, DMSc       anders.jakobsen@rsyd.dk   
Principal Investigator: Christine V. Madsen, MD         
Sub-Investigator: Parvin Adimi, MD         
Sponsors and Collaborators
Vejle Hospital
Sanofi
Investigators
Study Chair: Anders Jakobsen, DMSc Vejle Hospital
Principal Investigator: Christine V Madsen, MD Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01747239     History of Changes
Other Study ID Numbers: TaxOvar
Study First Received: December 6, 2012
Last Updated: March 28, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Vejle Hospital:
Ovarian cancer
Platinum refractory

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

ClinicalTrials.gov processed this record on April 15, 2014