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Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02705300
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:

Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.

The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Irinotecan 165 mg/m2 iv Drug: Oxaliplatin 85 mg/m2 iv Drug: Calcium folinate 200 mg/m2 iv Drug: 5-fluorouracil 3200 mg/m2 Dietary Supplement: Tocotrienol Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy plus tocotrienol

Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.

Daily: Tocotrienol 300 mg x 3 daily

Drug: Irinotecan 165 mg/m2 iv
Max. 4 months

Drug: Oxaliplatin 85 mg/m2 iv
Max. 4 months

Drug: Calcium folinate 200 mg/m2 iv
Max. 6 months

Drug: 5-fluorouracil 3200 mg/m2
Max. 6 months

Dietary Supplement: Tocotrienol
Max. 2 years or at the discretion of the investigator

Placebo Comparator: Chemotherapy plus placebo

Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.

Daily: Placebo x 3 daily

Drug: Irinotecan 165 mg/m2 iv
Max. 4 months

Drug: Oxaliplatin 85 mg/m2 iv
Max. 4 months

Drug: Calcium folinate 200 mg/m2 iv
Max. 6 months

Drug: 5-fluorouracil 3200 mg/m2
Max. 6 months

Drug: Placebo
Max. 2 years or at the discretion of the investigator




Primary Outcome Measures :
  1. Time to first serious adverse event [ Time Frame: 6 months after the last patient has finished chemotherapy ]

Secondary Outcome Measures :
  1. Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  2. Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  3. Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  4. Response rate [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  5. Progression free survival [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  6. Overall survival [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  7. Number of patients with treatment related adverse events as assessed by CTCAE v.4.0 [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  8. Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29 [ Time Frame: 6 months after the last patient has finished chemotherapy ]
  9. Resection rate [ Time Frame: 6 months after the last patient has finished chemotherapy ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically verified colorectal adenocarcinoma.
  • Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease
  • > 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer
  • Disease evaluable according to RECIST 1.1, but not necessarily measurable disease.
  • Age 18-75 years
  • Performance status (PS) 0-1. If age 71-75, then PS 0
  • Life expectancy > 3 months
  • Organ and bone marrow function as follows:

    • Neutrophil count ≥ 1.5 x 10^9/L
    • Thrombocytes ≥ 100 x 10^9/L
    • Total bilirubin ≤ 1.5 x upper level of normal (ULN)
    • Alanine transaminase (ALAT) ≤ 2.5 x ULN (or≤ 5 x ULN in case of liver metastases)
  • Fertile women must present negative pregnancy test. Male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment.
  • Orally and written informed consent to treatment and biobank

Exclusion Criteria:

  • Primarily resectable metastases
  • Chemotherapy, radiotherapy or immunotherapy within 4 weeks
  • Known neuropathy ≥ grade 2
  • Serious competitive medical condition
  • Other concurrent malignant disease other than non-melanoma skin cancer
  • Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine.
  • Hypersensitivity to one or more of the active substances or auxilliary agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705300


Contacts
Contact: Lars H Jensen, PhD lars.henrik.jensen@rsyd.dk
Contact: Louise R Larsen, MD louise.raunkilde.larsen@rsyd.dk

Locations
Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Lars H Jensen, PhD       lars.henrik.jensen@rsyd.dk   
Principal Investigator: Louise R Larsen, MD         
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Lars H Jensen, PhD Department of Oncology, Vejle Hospital
Principal Investigator: Louise R Larsen, MD Department of Oncology, Vejle Hospital

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02705300     History of Changes
Other Study ID Numbers: FOLFOXIRI-Toco
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Oxaliplatin
Irinotecan
Fluorouracil
Tocotrienols
Vitamin E
Tocopherols
Leucovorin
Levoleucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic