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Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer (Toco-CoR)

V

Vejle Hospital

Status and phase

Enrolling
Phase 2

Conditions

Colorectal Cancer Metastatic

Treatments

Drug: Bevacizumab
Drug: Capecitabine
Dietary Supplement: Tocotrienol
Drug: Oxaliplatin
Drug: Calcium folinate
Drug: Fluorouracil
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04245865
Toco-CoR

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

74 participants in 2 patient groups, including a placebo group

Arm A, standard treatment + tocotrienol
Experimental group
Description:
Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol
Treatment:
Drug: Oxaliplatin
Drug: Fluorouracil
Dietary Supplement: Tocotrienol
Drug: Calcium folinate
Drug: Bevacizumab
Drug: Capecitabine
Arm B, standard treatment + placebo
Placebo Comparator group
Description:
Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo
Treatment:
Drug: Oxaliplatin
Other: Placebo
Drug: Fluorouracil
Drug: Calcium folinate
Drug: Bevacizumab
Drug: Capecitabine

Trial contacts and locations

1

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Central trial contact

Natacha Trabjerg, MD

Data sourced from clinicaltrials.gov

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