Cabazitaxel in Platinum Refractory Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
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

December 6, 2012
March 28, 2014
January 2013
July 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01747239 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Cabazitaxel tolerability [ Time Frame: Every 3 weeks until progression or unacceptable toxicity, up to two years. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months up to three years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cabazitaxel in Platinum Refractory Ovarian Cancer
Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: Cabazitaxel
25 mg/m2 IV every three weeks
Experimental: Cabazitaxel
25 mg/m2 IV every three weeks
Intervention: Drug: Cabazitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2015
July 2015   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact: Anders Jakobsen, DMSc anders.jakobsen@rsyd.dk
Denmark
 
NCT01747239
TaxOvar
Yes
Vejle Hospital
Vejle Hospital
Sanofi
Study Chair: Anders Jakobsen, DMSc Vejle Hospital
Principal Investigator: Christine V Madsen, MD Vejle Hospital
Vejle Hospital
March 2014

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