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Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer Recurrent

Status

Recruiting

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Bevacizumab

Tocotrienol

About this trial

This is an interventional treatment trial for Ovarian Cancer Recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Department of Oncology, Vejle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: Discontinue treatment after first treatment cycle

Arm B: Continue treatment until progression

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

Response rate as measured by RECIST 1.1 or CA-125

Safety as measured by CTC version 5.0

CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)

Full Information

NCT ID

NCT04175470

First Posted

November 14, 2019

Last Updated

May 19, 2023

Sponsor

Vejle Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04175470

Brief Title

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Official Title

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 29, 2019 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer Recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Discontinue treatment after first treatment cycle

Arm Type

Experimental

Arm Title

Arm B: Continue treatment until progression

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

10 mg/kg intravenously every three weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Tocotrienol

Intervention Description

Capsules, 300 mg orally three times daily

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

6 months after enrollment of the last patient

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

12 months after enrollment of the last patient

Title

Response rate as measured by RECIST 1.1 or CA-125

Time Frame

6 months after enrollment of the last patient

Title

Safety as measured by CTC version 5.0

Description

CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)

Time Frame

Every 9 weeks until progression, up to 3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Louise Faaborg, MD

Phone

+45 7940 5446

louise.faaborg.larsen@rsyd.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Torben F Hansen, MD, DMSc

Organizational Affiliation

Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Oncology, Vejle Hospital

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louise Faaborg, MD

louise.faaborg.larsen@rsyd.dk

12. IPD Sharing Statement

Learn more about this trial

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

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