Cabazitaxel in Platinum Refractory Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01747239
• Other study ID #: TaxOvar
• Status: Terminated
• Phase: Phase 2
• First received: December 6, 2012
• Last updated: December 3, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Cabazitaxel
25 mg/m2 IV every three weeks

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aalborg Hospital	Aalborg
Denmark	Herlev Hospital	Herlev
Denmark	Department of Oncology, Odense University Hospital	Odense
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Vejle Hospital	Sanofi

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of response to cabazitaxel	Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan	Every 9 weeks up to two years	No
Secondary	Progression free survival		Every three months until progression or death, up to three years	No
Secondary	Overall survival		Every 3 months up to three years	No