Ovarian CancerPhase 2NCT01747239
Cabazitaxel in Platinum Refractory Ovarian Cancer
A Phase 2 study testing Cabazitaxel in people with Ovarian Cancer, run by Vejle Hospital at 4 sites in Denmark.
Trial summary
Ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. This constitutes a major therapeutic problem and new treatment approaches are highly needed. 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
- 4 participants
- Where
- 4 sitesDenmark
- Study dates
- Jan 2013to Jul 2014
- 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. Stages I-IV.
- Patients with refractory disease defined as progression or no change during primary treatment, as evaluated after 3 and/or 6 cycles of platinum/paclitaxel. Prior to inclusion, patients must have received platinum and paclitaxel as combination treatment.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or evaluable by Gynecologic Cancer Interest Group (GCIG) cancer antigen 125 (CA-125) criteria.
- Age ≥ 18 years.
- Performance stage 0-2.
- Adequate bone marrow function, liver function, renal function, and coagulation parameters (within 7 days prior to inclusion):
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- Neutrophils (ANC) ≥ 1.5 x 10^9/l
- Platelet count ≥ 100 x 10^9/l
- Serum bilirubin ≤ 1.0 x upper limit of normal (ULN)
- Serum transaminase ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)and patients with creatinine clearance <60 mL/min should be excluded
- 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.
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P4503A4/5 (a one 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.
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- 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.
- Treatment with disulfiram (antabuse)
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Department of Oncology, Aalborg Hospital
Aalborg, DK-9100
Herlev Hospital
Herlev
Department of Oncology, Odense University Hospital
Odense
Department of Oncology, Vejle Hospital
Vejle, DK-7100
About this study
Official title: Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial
Ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. This constitutes a major therapeutic problem and new treatment approaches are highly needed.
Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has effect in patients refractory to taxotere. Consequently, it could be anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Cabazitaxel
- Keywords
- Ovarian cancer, Platinum refractory
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
25 mg/m2 IV every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | 25 mg/m2 IV every three weeks Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of response to cabazitaxel
Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan
Measured: Every 9 weeks up to two years
Secondary outcomes (2)
Progression free survival
Measured: Every three months until progression or death, up to three years
Overall survival
Measured: Every 3 months up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Too low inclusion rate. Only 4 patients included over 16 months
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, DMSc, Study chair, Vejle HospitalChristine V Madsen, MD, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747239
- Sponsor's protocol ID
- TaxOvar
- Status last verified
- Dec 2014
- First submitted
- 6 Dec 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabazitaxel in Platinum Refractory Ovarian Cancer. A Phase II Trial
- ClinicalTrials.gov ID
- NCT01747239
- Acronym / sponsor ID
- TaxOvar
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Platinum refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too low inclusion rate. Only 4 patients included over 16 months
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Dec 2012 (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.
Ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. This constitutes a major therapeutic problem and new treatment approaches are highly needed.
Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has effect in patients refractory to taxotere. Consequently, it could be anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.
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 IV every three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
- Patients with refractory disease defined as progression or no change during primary treatment, as evaluated after 3 and/or 6 cycles of platinum/paclitaxel. Prior to inclusion, patients must have received platinum and paclitaxel as combination treatment.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or evaluable by Gynecologic Cancer Interest Group (GCIG) cancer antigen 125 (CA-125) criteria.
- Age ≥ 18 years.
- Performance stage 0-2.
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.
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P4503A4/5 (a one 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.
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 |
|---|---|---|
| Cabazitaxel25 mg/m2 IV every three weeks | Drug | Cabazitaxel |
Primary outcome
Rate of response to cabazitaxel
Time frame: Every 9 weeks up to two years
Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan
2 secondary outcomes
Progression free survival
Time frame: Every three months until progression or death, up to three years
Overall survival
Time frame: Every 3 months up to three years
Results and safety
The study was stopped early (reason given: Too low inclusion rate. Only 4 patients included over 16 months). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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.
Anders Jakobsen, DMSc study chair
Vejle Hospital
Christine V Madsen, MD principal investigator
Vejle Hospital
4 sites 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 4 sites 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 12 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: stopped early, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: Too low inclusion rate. Only 4 patients included over 16 months). Results are not available in the source record.
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?
Rate of response to cabazitaxel (time frame: Every 9 weeks up to two years). 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 4 Dec 2014.