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

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ClinicalTrials.gov Identifier: NCT02560337
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : May 1, 2018
Sponsor:
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.

Tocotrienol is a fraction of the natural E-vitamin with several biological effects, including effect on malignant cells and angiogenesis.

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

In case of progression on cabazitaxel there is an option of crossing over to tocotrienol and vice versa.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cabazitaxel vs. Tocotrienol in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase 2 Randomized, Open-label Study
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019


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.

On progression there is an option of crossing over to tocotrienol.

Drug: Cabazitaxel
Other Name: Jevtana

Experimental: Tocotrienol

900 mg (300 mg x 3 every day) until progression or unacceptable toxicity.

On progression there is an option of crossing over to cabazitaxel.

Drug: Tocotrienol



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

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Every 9 weeks from date of randomization 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 randomization 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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02560337


Contacts
Contact: Karina D Steffensen, MD, PhD karina.dahl.steffensen@rsyd.dk

Locations
Denmark
Vejle Hospital, Department of Oncology Recruiting
Vejle, Denmark
Contact: Karina D Steffensen, MD, PhD       Karina.dahl.steffensen@rsyd.dk   
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Karina D Steffensen Vejle Hospital, Department of Oncology

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02560337     History of Changes
Other Study ID Numbers: CaTo-ROC
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: May 2018

Keywords provided by Vejle Hospital:
Ovarian cancer
Relapse
Recurrence
Chemotherapy resistance

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances