Tocotrienol and Bevacizumab in metastatic colorectal cancer.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 74

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):
oWBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l
oPlatelet count = 100 x 10^9/l
oHemoglobin = 6.0 mmol/l
oSerum bilirubin = 2.0 x ULN
oSerum transaminase = 2.5 x ULN
oSerum 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the present study is to compare the effect and toxicity of standard chemotherapy and bevacizumab with the same regimen supplemented with tocotrienol in metastatic colorectal cancer.;Secondary Objective: Not applicable;Primary end point(s): The rate of progression free patients at six months;Timepoint(s) of evaluation of this end point: 6 months after enrollment of the last patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Translational research of selected biomarkers<br>2. Toxicity<br>3. Time to serious adverse event (SAE)<br>4. Response rate<br>5. Overall survival<br>;Timepoint(s) of evaluation of this end point: 1. 1 year after enrollment of the last patient<br>2. 6 months after enrollment of the last patient<br>3. 6 months after enrollment of the last patient<br>4. 6 months after enrollment of the last patient<br>5. 2 years after enrollment of the last patient

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