Description:
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.
Title
- Brief Title: Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer
- Official Title: Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial
Clinical Trial IDs
- ORG STUDY ID:
BeTo-Ovar
- NCT ID:
NCT04175470
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Bevacizumab | | Arm A: Discontinue treatment after first treatment cycle |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Discontinue treatment after first treatment cycle | Experimental | | |
Arm B: Continue treatment until progression | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival |
Time Frame: | 6 months after enrollment of the last patient |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | 12 months after enrollment of the last patient |
Safety Issue: | |
Description: | |
Measure: | Response rate as measured by RECIST 1.1 or CA-125 |
Time Frame: | 6 months after enrollment of the last patient |
Safety Issue: | |
Description: | |
Measure: | Safety as measured by CTC version 5.0 |
Time Frame: | Every 9 weeks until progression, up to 3 years |
Safety Issue: | |
Description: | CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC) |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Vejle Hospital |
Last Updated
April 29, 2021