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Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175470
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Drug: Bevacizumab Dietary Supplement: Tocotrienol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial
Actual Study Start Date : October 29, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Arm A: Discontinue treatment after first treatment cycle Drug: Bevacizumab
10 mg/kg intravenously every three weeks

Dietary Supplement: Tocotrienol
Capsules, 300 mg orally three times daily

Experimental: Arm B: Continue treatment until progression Drug: Bevacizumab
10 mg/kg intravenously every three weeks

Dietary Supplement: Tocotrienol
Capsules, 300 mg orally three times daily




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 6 months after enrollment of the last patient ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months after enrollment of the last patient ]
  2. Response rate as measured by RECIST 1.1 or CA-125 [ Time Frame: 6 months after enrollment of the last patient ]
  3. Safety as measured by CTC version 5.0 [ Time Frame: Every 9 weeks until progression, up to 3 years ]
    CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175470


Contacts
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Contact: Louise Faaborg, MD +45 7940 5446 louise.faaborg.larsen@rsyd.dk

Locations
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Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, 7100
Contact: Louise Faaborg, MD       louise.faaborg.larsen@rsyd.dk   
Sponsors and Collaborators
Vejle Hospital
Investigators
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Study Chair: Karina D Steffensen, MD, PhD Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT04175470    
Other Study ID Numbers: BeTo-Ovar
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tocotrienols
Vitamin E
Tocopherols
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins