Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

STATUS

Recruiting
End date

Dec 28, 2026
participants needed

74
sponsor

Vejle Hospital

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Updated on 19 February 2024

See if I qualify

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	18years - 100years
Treatment	Placebo, Bevacizumab, Capecitabine, Fluorouracil, Oxaliplatin, Calcium folinate, Tocotrienol
Clinical Study Identifier	NCT04245865
Sponsor	Vejle Hospital
Last Modified on	19 February 2024

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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

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Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer