Clinical Trials /

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

NCT04175470

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Ovarian Cancer Recurrent

Interventions

DrugSynonymsArms
BevacizumabArm 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

NameTypeDescriptionInterventions
Arm A: Discontinue treatment after first treatment cycleExperimental
  • Bevacizumab
Arm B: Continue treatment until progressionExperimental
  • Bevacizumab

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

May 14, 2020