Toco-CoR: Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

Sponsor
Vejle Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04245865
Collaborator
(none)
74
1
2
39.2
1.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial
Actual Study Start Date :
Jun 26, 2020
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A, standard treatment + tocotrienol

Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol

Drug: Fluorouracil
2800 mg/m2 iv

Drug: Calcium folinate
400 mg/m2 iv

Drug: Oxaliplatin
85 mg/m2 iv

Drug: Bevacizumab
5 mg/kg OR 7.5 mg/kg iv

Drug: Capecitabine
2000 mg/m2 orally daily for two weeks

Dietary Supplement: Tocotrienol
300 mg orally x 3 daily

Placebo Comparator: Arm B, standard treatment + placebo

Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo

Drug: Fluorouracil
2800 mg/m2 iv

Drug: Calcium folinate
400 mg/m2 iv

Drug: Oxaliplatin
85 mg/m2 iv

Drug: Bevacizumab
5 mg/kg OR 7.5 mg/kg iv

Drug: Capecitabine
2000 mg/m2 orally daily for two weeks

Other: Placebo
Placebo orally x 3 daily

Outcome Measures

Primary Outcome Measures

  1. The rate of progression free patients at six months [Six months after enrollment of the last patient]

Secondary Outcome Measures

  1. Time to first serious adverse event according to CTCAE 5.0 [Six months after enrollment of the last patient]

    CTCAE=Common Terminology Criteria for Adverse Events

  2. Response rate as measured by RECIST 1.1 [Six months after enrollment of the last patient]

    RECIST=Response evaluation criteria in solid tumors

  3. Overall survival [12 months after enrollment of the last patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Oncology, Vejle Hospital Vejle Denmark 7100

Sponsors and Collaborators

  • Vejle Hospital

Investigators

  • Study Chair: Torben F Hansen, MD, PhD, Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT04245865
Other Study ID Numbers:
  • Toco-CoR
First Posted:
Jan 29, 2020
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vejle Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022