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Cabazitaxel in Platinum Refractory Ovarian Cancer

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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
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Vejle Hospital

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE December 11, 2012
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Progression free survival [ Time Frame: Every three months until progression or death, up to three years ]
  • Overall survival [ Time Frame: Every 3 months up to three years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • Cabazitaxel tolerability [ Time Frame: Every 3 weeks until progression or unacceptable toxicity, up to two years. ]
    Blood count will be monitored weekly during the first treatment cycle.
  • Progression free survival [ Time Frame: Every three months until progression or death, up to three years ]
  • Overall survival [ Time Frame: Every 3 months up to three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cabazitaxel in Platinum Refractory Ovarian Cancer
Official Title  ICMJE Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: Cabazitaxel
25 mg/m2 IV every three weeks
Study Arms  ICMJE Experimental: Cabazitaxel
25 mg/m2 IV every three weeks
Intervention: Drug: Cabazitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
4
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2012)
40
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01747239
Other Study ID Numbers  ICMJE TaxOvar
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vejle Hospital
Study Sponsor  ICMJE Vejle Hospital
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Chair: Anders Jakobsen, DMSc Vejle Hospital
Principal Investigator: Christine V Madsen, MD Vejle Hospital
PRS Account Vejle Hospital
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP