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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02560337
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Cabazitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase II Trial
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Cabazitaxel

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 Name: Jevtana

Primary Outcome Measures :
  1. Number of patients alive and without progression after three months of treatment [ Time Frame: 3 months after start of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Overall survival [ Time Frame: Every three months up to 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02560337

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Vejle Hospital, Department of Oncology
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
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Study Chair: Karina D Steffensen Vejle Hospital, Department of Oncology
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Responsible Party: Vejle Hospital Identifier: NCT02560337    
Other Study ID Numbers: CaTo-ROC
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Vejle Hospital:
Ovarian cancer
Chemotherapy resistance
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type