A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

Sponsor
Epidemiological and Clinical Research Information Network
Study ID
NCT01996306
Phase
PHASE3
Status
Completed

Conditions

  • Colorectal Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Intestinal Neoplasms
  • Neoplasm Metastasis

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
  • CPT-11 (Irinotecan) — DRUG
    150-180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle.
  • 5-FU Bolus — DRUG
    400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
  • 5-FU Infusion — DRUG
    2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
  • l-LV (dl-LV) — DRUG
    200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
  • bevacizumab — BIOLOGICAL
    7.5mg/kg IV intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on Day 1 of a 3-week cycle.
  • CPT-11 (Irinotecan) — DRUG
    150-200 mg/m2 intravenously administered over 90 minutes on day 1 of a 3-week cycle.
  • Capecitabine — DRUG
    1600mg/m2/day oral on day 1 (evening) to day 15 (morning)of a 3-week cycle.

Study Details

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Key Dates

Start date
Dec 2, 2013
Status verified
Jan 2019
Primary completion
Nov 20, 2017
Completion
Jun 30, 2018

Study Design

Enrollment
650 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFIRI +/- Bevacizumab
    Bevacizumab 5 mg/kg IV 90-30 min Day 1 CPT-11 180 mg/m2 (150 mg/m2) IV 90 min Day 1 l-LV (dl-LV) 200 mg/m2 (400 mg/m2) IV 120 min Day 1 5-FU - bolus 400 mg/m2 IV bolus Day 1 5-FU - infusional 2400 mg/m2 IV continuous (46 hours) Day 1 - 3
  • Experimental: XELIRI +/- Bevacizumab
    Bevacizumab 7.5 mg/kg IV 90-30 min Day 1 CPT-11 200 mg/m2 (150 mg/m2) IV 90 min Day 1 Capecitabine 800 mg/m2 p.o. twice daily 14 Days consecutively

Primary Outcome Measure

Overall survival [ Time Frame: Assessed until 1.5 years after the last patient enrolment ]

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