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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients alive and without progression after three months of treatment | 3 months after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 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 | 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 |
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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):
Remaining life expectancy of at least 3 months
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina D Steffensen | Vejle Hospital, Department of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vejle Hospital, Department of Oncology | Vejle | Denmark |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C552428 | cabazitaxel |
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| Overall survival | Every three months up to 24 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |