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

November 29, 2023 updated by: Vejle Hospital

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Recruiting
        • Department of Oncology, Vejle Hospital
        • Principal Investigator:
          • Natacha Trabjerg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A, standard treatment + tocotrienol
Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol
Drug: Fluorouracil
2800 mg/m2 iv
Drug: Calcium folinate
400 mg/m2 iv
Drug: Oxaliplatin
85 mg/m2 iv
Drug: Bevacizumab
5 mg/kg OR 7.5 mg/kg iv
Drug: Capecitabine
2000 mg/m2 orally daily for two weeks
Dietary supplement: Tocotrienol
300 mg orally x 3 daily
Placebo Comparator: Arm B, standard treatment + placebo
Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo
Drug: Fluorouracil
2800 mg/m2 iv
Drug: Calcium folinate
400 mg/m2 iv
Drug: Oxaliplatin
85 mg/m2 iv
Drug: Bevacizumab
5 mg/kg OR 7.5 mg/kg iv
Drug: Capecitabine
2000 mg/m2 orally daily for two weeks
Other: Placebo
Placebo orally x 3 daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of progression free patients at six months
Time Frame: Six months after enrollment of the last patient
Six months after enrollment of the last patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first serious adverse event according to CTCAE 5.0
Time Frame: Six months after enrollment of the last patient
CTCAE=Common Terminology Criteria for Adverse Events
Six months after enrollment of the last patient
Response rate as measured by RECIST 1.1
Time Frame: Six months after enrollment of the last patient
RECIST=Response evaluation criteria in solid tumors
Six months after enrollment of the last patient
Overall survival
Time Frame: 12 months after enrollment of the last patient
12 months after enrollment of the last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Torben F Hansen, MD, PhD, Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Toco-CoR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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