A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Irinotecan 165 mg/m2 iv
- Conditions
- Colorectal Cancer
- Sponsor
- Vejle Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Time to first serious adverse event
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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-
- •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
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
Arms & Interventions
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
Intervention: Irinotecan 165 mg/m2 iv
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
Intervention: Oxaliplatin 85 mg/m2 iv
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
Intervention: Calcium folinate 200 mg/m2 iv
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
Intervention: 5-fluorouracil 3200 mg/m2
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
Intervention: Tocotrienol
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
Intervention: Irinotecan 165 mg/m2 iv
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
Intervention: Oxaliplatin 85 mg/m2 iv
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
Intervention: Calcium folinate 200 mg/m2 iv
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
Intervention: 5-fluorouracil 3200 mg/m2
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
Intervention: Placebo
Outcomes
Primary Outcomes
Time to first serious adverse event
Time Frame: 6 months after the last patient has finished chemotherapy
Secondary Outcomes
- Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy(6 months after the last patient has finished chemotherapy)
- Number of patients with treatment related adverse events as assessed by CTCAE v.4.0(6 months after the last patient has finished chemotherapy)
- Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy(6 months after the last patient has finished chemotherapy)
- Progression free survival(6 months after the last patient has finished chemotherapy)
- Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29(6 months after the last patient has finished chemotherapy)
- Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy(6 months after the last patient has finished chemotherapy)
- Response rate(6 months after the last patient has finished chemotherapy)
- Overall survival(6 months after the last patient has finished chemotherapy)
- Resection rate(6 months after the last patient has finished chemotherapy)