Ovarian Cancer RecurrentPhase 2NCT04175470
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer
A Phase 2 study testing Bevacizumab and Tocotrienol in people with Ovarian Cancer Recurrent, run by Vejle Hospital at 1 site in Denmark.
Trial summary
A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- Bevacizumab and Tocotrienol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Oct 2019to 31 Dec 2024
- 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 ovarian cancer, primary fallopian or primary peritoneal cancer.
- Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens
- Progression on previous treatment. Previous treatment with bevacizumab is allowed.
- Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria.
- Age ≥ 18 years.
- Performance status 0-2.
Show all 15Show fewer
- Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
- Platelet count ≥ 100 x 10^9/l
- Hemoglobin ≥ 6 mmol/l
- Serum bilirubin < 2.0 x ULN
- Serum transaminase ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 ULN
- Urine dipstick for protein < 2+. If the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents < 1 g.
- Written informed consent
Who cannot join
- Other malignant disease within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin.
- Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
- Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
- Underlying medical disease not adequately treated (diabetes, cardiac disease).
- Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment).
- Surgery including open biopsy, within 4 weeks prior to first dose of bevacizumab.
Show all 16Show fewer
- Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months before start of treatment.
- Clinical significant cardiovascular disease, including:
- Myocardial infarction or unstable angina within 6 months before start of treatment
- New York Heart Association (NYHA) class ≥ 2
- Poorly controlled cardiac arrhythmia despite medication
- Peripheral vascular disease grade ≥ 3
- Allergy to active substance or any of the auxiliary agents
- Bleeding tumor
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial
A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood.
The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only.
Read more
When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did.
Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- Bevacizumab, Tocotrienol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
10 mg/kg intravenously every three weeks
TocotrienolDietary supplement
Capsules, 300 mg orally three times daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Discontinue treatment after first treatment cycle | Experimental | Not described Receives: Drug: Bevacizumab; Dietary Supplement: Tocotrienol |
| Arm B: Continue treatment until progression | Experimental | Not described Receives: Drug: Bevacizumab; Dietary Supplement: Tocotrienol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 6 months after enrollment of the last patient
Secondary outcomes (3)
Overall survival
Measured: 12 months after enrollment of the last patient
Response rate as measured by RECIST 1.1 or CA-125
Measured: 6 months after enrollment of the last patient
Safety as measured by CTC version 5.0
CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)
Measured: Every 9 weeks until progression, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start29 Oct 2019
- Primary completion30 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben F Hansen, MD, DMSc, Study chair, Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175470
- Sponsor's protocol ID
- BeTo-Ovar
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2019
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial
- ClinicalTrials.gov ID
- NCT04175470
- Acronym / sponsor ID
- BeTo-Ovar
- Conditions
- Ovarian Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Nov 2019 (actual)
- 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.
A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood.
The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only.
When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did.
Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Discontinue treatment after first treatment cycle | Experimental | Drug: Bevacizumab, Dietary Supplement: Tocotrienol |
| Arm B: Continue treatment until progression | Experimental | Drug: Bevacizumab, Dietary Supplement: Tocotrienol |
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 ovarian cancer, primary fallopian or primary peritoneal cancer.
- Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens
- Progression on previous treatment. Previous treatment with bevacizumab is allowed.
- Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria.
- Age ≥ 18 years.
Key exclusion criteria (16 listed)
- Other malignant disease within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin.
- Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
- Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
- Underlying medical disease not adequately treated (diabetes, cardiac disease).
- Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment).
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 |
|---|---|---|
| Bevacizumab10 mg/kg intravenously every three weeks | Drug | Arm A: Discontinue treatment after first treatment cycle, Arm B: Continue treatment until progression |
| TocotrienolCapsules, 300 mg orally three times daily | Dietary supplement | Arm A: Discontinue treatment after first treatment cycle, Arm B: Continue treatment until progression |
Primary outcome
Progression free survival
Time frame: 6 months after enrollment of the last patient
3 secondary outcomes
Overall survival
Time frame: 12 months after enrollment of the last patient
Response rate as measured by RECIST 1.1 or CA-125
Time frame: 6 months after enrollment of the last patient
Safety as measured by CTC version 5.0
Time frame: Every 9 weeks until progression, up to 3 years
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 3 Jan 2025.
Related trials for Ovarian Cancer Recurrent
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
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.
Torben F Hansen, MD, DMSc study chair
Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
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 Bevacizumab and Tocotrienol in people with Ovarian Cancer Recurrent, 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 16 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 3 Jan 2025. 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?
Progression free survival (time frame: 6 months after enrollment of the last patient). 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 3 Jan 2025.