Back to resultsCabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy. (CaTo-ROC)
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cabazitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Relapse, Recurrence, Chemotherapy resistance
Eligibility Criteria
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):
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Vejle Hospital, Department of Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabazitaxel
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of patients alive and without progression after three months of treatment
Secondary Outcome Measures
Response rate
Progression free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02560337
Brief Title
Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.
Acronym
CaTo-ROC
Official Title
Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 5, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer, Relapse, Recurrence, Chemotherapy resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel
Other Intervention Name(s)
Jevtana
Primary Outcome Measure Information:
Title
Number of patients alive and without progression after three months of treatment
Time Frame
3 months after start of treatment
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Overall survival
Time Frame
Every three months up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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):
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karina D Steffensen
Organizational Affiliation
Vejle Hospital, Department of Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital, Department of Oncology
City
Vejle
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.
We'll reach out to this number within 24 hrs