Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy. (CaTo-ROC)

October 6, 2020 updated by: Vejle Hospital

Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase II Trial

Many ovarian cancer patients have been offered different standard cytostatics and gradually develop chemo-resistance. However, a considerable fraction of these patients are still in good general health and have a strong wish for further treatment.

Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer.

The aim of the study is to investigate whether cabazitaxel could be a reasonable treatment option in patients with chemo-resistant and refractory ovarian cancer with regard to effect and toxicity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark
        • Vejle Hospital, Department of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Platinum resistant ovarian cancer with at least two previous cytostatic regimens or platinum-refractory disease defined as progression while receiving the last line of platinum based therapy or within 4 weeks of last platinum dose
  • Progression on previous treatment.
  • Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria
  • Age ≥ 18 years.
  • Performance status 0-2.

  • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

    • Neutrophils (ANC) ≥ 1.5 * 10^9/l
    • Platelet count ≥ 100 * 10^9/l
    • Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/l
    • Serum bilirubin ≤ 1.0 * ULN
    • Serum transaminase ≤ 2.5 * ULN
    • Serum creatinine ≤ 1.5 ULN (at creatinine above 1.5 x ULN measured GFR must be at least 50 ml / min)
  • Remaining life expectancy of at least 3 months
  • 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.
  • Allergy to the active substance or any of the auxiliary agents.
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabazitaxel

25 mg/m2 administered as a one hour intravenous infusion on day 1 of a 3-week cycle.

Treatment continues until progression or unacceptable toxicity.
Drug: Cabazitaxel
Other Names:
  • Jevtana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients alive and without progression after three months of treatment
Time Frame: 3 months after start of treatment
3 months after start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months
Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months
Progression free survival
Time Frame: Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months
Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months
Overall survival
Time Frame: Every three months up to 24 months
Every three months up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Karina D Steffensen, Vejle Hospital, Department of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 5, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaTo-ROC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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