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Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer (Toco-CoR)

Primary Purpose

Colorectal Cancer Metastatic

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Fluorouracil
Calcium folinate
Oxaliplatin
Bevacizumab
Capecitabine
Tocotrienol
Placebo
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring Colorectal cancer, Tocotrienol, Natural killer cells, Circulating tumor DNA

Eligibility Criteria

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

Inclusion Criteria:

  • Histopathologically verified adenocarcinoma of the colon or rectum
  • Metastatic disease
  • Planned treatment with FOLFOX or capecitabine combined with bevacizumab
  • Evaluable disease according to RECIST 1.1
  • Performance status 0-2
  • Expected survival ≥ 3 months
  • Patient acceptance to collection of blood samples for translational research
  • Age ≥ 18 years
  • Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.

  • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

    • WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
    • Platelet count ≥ 100 x 10^9/l
    • Hemoglobin ≥ 6.0 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 ≤ 1g.
  • Written and orally informed consent

Exclusion Criteria:

  • Other active malignant disease within 5 years prior to inclusion in the study.
  • Other experimental therapy within 28 days prior to treatment initiation.
  • Underlying medical disease not adequately treated.
  • Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.
  • Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment
  • Bleeding tumor
  • Pregnant or breastfeeding women
  • Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment.
  • Hypersensitivity to one or more active substances or auxiliary substances

Sites / Locations

  • Department of Oncology, Vejle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A, standard treatment + tocotrienol

Arm B, standard treatment + placebo

Arm Description

Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol

Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo

Outcomes

Primary Outcome Measures

The rate of progression free patients at six months

Secondary Outcome Measures

Time to first serious adverse event according to CTCAE 5.0
CTCAE=Common Terminology Criteria for Adverse Events
Response rate as measured by RECIST 1.1
RECIST=Response evaluation criteria in solid tumors
Overall survival

Full Information

First Posted
January 27, 2020
Last Updated
June 2, 2023
Sponsor
Vejle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04245865
Brief Title
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer
Acronym
Toco-CoR
Official Title
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
Keywords
Colorectal cancer, Tocotrienol, Natural killer cells, Circulating tumor DNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A, standard treatment + tocotrienol
Arm Type
Experimental
Arm Description
Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol
Arm Title
Arm B, standard treatment + placebo
Arm Type
Placebo Comparator
Arm Description
Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
2800 mg/m2 iv
Intervention Type
Drug
Intervention Name(s)
Calcium folinate
Intervention Description
400 mg/m2 iv
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/m2 iv
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
5 mg/kg OR 7.5 mg/kg iv
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
2000 mg/m2 orally daily for two weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Tocotrienol
Intervention Description
300 mg orally x 3 daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo orally x 3 daily
Primary Outcome Measure Information:
Title
The rate of progression free patients at six months
Time Frame
Six months after enrollment of the last patient
Secondary Outcome Measure Information:
Title
Time to first serious adverse event according to CTCAE 5.0
Description
CTCAE=Common Terminology Criteria for Adverse Events
Time Frame
Six months after enrollment of the last patient
Title
Response rate as measured by RECIST 1.1
Description
RECIST=Response evaluation criteria in solid tumors
Time Frame
Six months after enrollment of the last patient
Title
Overall survival
Time Frame
12 months after enrollment of the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically verified adenocarcinoma of the colon or rectum Metastatic disease Planned treatment with FOLFOX or capecitabine combined with bevacizumab Evaluable disease according to RECIST 1.1 Performance status 0-2 Expected survival ≥ 3 months Patient acceptance to collection of blood samples for translational research Age ≥ 18 years Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted. Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 10^9/l Platelet count ≥ 100 x 10^9/l Hemoglobin ≥ 6.0 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 ≤ 1g. Written and orally informed consent Exclusion Criteria: Other active malignant disease within 5 years prior to inclusion in the study. Other experimental therapy within 28 days prior to treatment initiation. Underlying medical disease not adequately treated. Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab. Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment Bleeding tumor Pregnant or breastfeeding women Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment. Hypersensitivity to one or more active substances or auxiliary substances
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha Trabjerg, MD
Phone
+45 7940 5446
Email
Natacha.dencker.trabjerg2@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben F Hansen, MD, PhD
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
Natacha Trabjerg, MD

12. IPD Sharing Statement

Learn more about this trial

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

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