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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Cabazitaxel

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, DK-9100
    • Department of Oncology, Aalborg Hospital
  • Herlev, Denmark
    • Herlev Hospital
  • Odense, Denmark
    • Department of Oncology, Odense University Hospital
  • Vejle, Denmark, DK-7100
    • Department of Oncology, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cabazitaxel; 25 mg/m2 IV every three weeks	Drug: Cabazitaxel; 25 mg/m2 IV every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	Every three months until progression or death, up to three years
Overall survival	Every 3 months up to three years

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Collaborators: Sanofi
• Investigators: Study Chair: Anders Jakobsen, DMSc, Vejle Hospital; Principal Investigator: Christine V Madsen, MD, Vejle Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Ovarian cancer; Platinum refractory
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: TaxOvar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No