Cabazitaxel vs. Tocotrienol 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02560337|
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : May 1, 2018
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|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
Other Name: Jevtana
900 mg (300 mg x 3 every day) until progression or unacceptable toxicity.
On progression there is an option of crossing over to cabazitaxel.
- Number of patients alive and without progression after three months of treatment with cabazitaxel or tocotrienol. [ Time Frame: 3 months after start of treatment ]
- 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 ]
- 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 ]
- Overall survival [ Time Frame: Every three months up to 24 months ]
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
|Contact: Karina D Steffensen, MD, PhDfirstname.lastname@example.org|
|Vejle Hospital, Department of Oncology||Recruiting|
|Contact: Karina D Steffensen, MD, PhD Karina.email@example.com|
|Study Chair:||Karina D Steffensen||Vejle Hospital, Department of Oncology|