Ovarian CancerPhase 2CaTo-ROCNCT02560337
Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.
A Phase 2 study testing Cabazitaxel in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to 1 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase II Trial
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.
- Conditions
- Ovarian Cancer
- Being tested
- Cabazitaxel
- Keywords
- Ovarian cancer, Relapse, Recurrence, Chemotherapy resistance
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtana
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients alive and without progression after three months of treatment
Measured: 3 months after start of treatment
Secondary outcomes (3)
Response rate
Measured: 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
Measured: 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
Measured: Every three months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion5 Dec 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karina D Steffensen, Study chair, Vejle Hospital, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560337
- Sponsor's protocol ID
- CaTo-ROC
- Acronym
- CaTo-ROC
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase II Trial
- ClinicalTrials.gov ID
- NCT02560337
- Acronym / sponsor ID
- CaTo-ROC / CaTo-ROC
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Relapse, Recurrence, Chemotherapy resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: Cabazitaxel25 mg/m2 administered as a one hour intravenous infusion on day 1 of a 3-week cycle. Treatment continues until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabazitaxelAlso: Jevtana | Drug | Cabazitaxel |
Primary outcome
Number of patients alive and without progression after three months of treatment
Time frame: 3 months after start of treatment
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina D Steffensen study chair
Vejle Hospital, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients alive and without progression after three months of treatment (time frame: 3 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.