Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy. (CaTo-ROC)
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|ClinicalTrials.gov Identifier: NCT02560337|
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : October 8, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Other Name: Jevtana
- Number of patients alive and without progression after three months of treatment [ Time Frame: 3 months after start of treatment ]
- 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 ]
- 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 ]
- 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
|Vejle Hospital, Department of Oncology|
|Study Chair:||Karina D Steffensen||Vejle Hospital, Department of Oncology|