Cabazitaxel in Platinum Refractory Ovarian Cancer

NCT ID: NCT01747239

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

25 mg/m2 IV every three weeks

Group Type: EXPERIMENTAL

Cabazitaxel

Intervention Type: DRUG

25 mg/m2 IV every three weeks

Interventions

Cabazitaxel

25 mg/m2 IV every three weeks

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Jakobsen, DMSc

Role: STUDY_CHAIR

Vejle Hospital

Christine V Madsen, MD

Role: PRINCIPAL_INVESTIGATOR

Vejle Hospital

Locations

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, , Denmark

Countries

Denmark

Other Identifiers

TaxOvar

Identifier Type: -

Identifier Source: org_study_id