Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 28, 2026
  • participants needed
    74
  • sponsor
    Vejle Hospital
Updated on 19 February 2024
cancer
hysterectomy
platelet count
renal function
metastasis
neutrophil count
oxaliplatin
adenocarcinoma
oophorectomy
bevacizumab
capecitabine
fluorouracil
leucovorin
serum bilirubin
bilateral oophorectomy
hormonal contraception
kidney function tests
folfox regimen
kidney function test
serum bilirubin level
adenocarcinoma of colon
metastatic colorectal cancer
adenocarcinoma of the colon
tubal occlusion
transient ischemic attack
investigational treatment
experimental therapy
tocotrienol
colorectal cancer
incision biopsy
disseminated cancer
cancer metastatic

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.

Details
Condition Colorectal Cancer Metastatic
Age 18-100 years
Treatment Placebo, Bevacizumab, Capecitabine, Fluorouracil, Oxaliplatin, Calcium folinate, Tocotrienol
Clinical Study IdentifierNCT04245865
SponsorVejle Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.