Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vejle Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer
