Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

— Toco-CoR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245865
• Other study ID #: Toco-CoR
• Status: Recruiting
• Phase: Phase 2
• Start date: June 26, 2020
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Vejle Hospital
• Contact: Natacha Trabjerg, MD
• Phone: +45 7940 5446
• Email: Natacha.dencker.trabjerg2[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Fluorouracil
2800 mg/m2 iv
• Calcium folinate
400 mg/m2 iv
• Oxaliplatin
85 mg/m2 iv
• Bevacizumab
5 mg/kg OR 7.5 mg/kg iv
• Capecitabine
2000 mg/m2 orally daily for two weeks

Dietary Supplement:
• Tocotrienol
300 mg orally x 3 daily

Other:
• Placebo
Placebo orally x 3 daily

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of progression free patients at six months		Six months after enrollment of the last patient
Secondary	Time to first serious adverse event according to CTCAE 5.0	CTCAE=Common Terminology Criteria for Adverse Events	Six months after enrollment of the last patient
Secondary	Response rate as measured by RECIST 1.1	RECIST=Response evaluation criteria in solid tumors	Six months after enrollment of the last patient
Secondary	Overall survival		12 months after enrollment of the last patient