Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases.

Sponsor
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Study ID
NCT04189055
Phase
PHASE2
Status
Unknown

Conditions

  • Cancer Colorectal

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
    Cetuximab 500mg/m² IV, day 1
  • Irinotecan — DRUG
    Irinotecan 180mg/m² IV, day 1

Study Details

The purpose of this study is to investigate the efficacy of cetuximab or cetuximab-irinotecan in patients with neo wild-type colorectal cancer who have been previously treated for metastatic disease. Patients will be included in cohort #1 or cohort #2. The inclusion in cohort #2 will start when the results of the cohort #1 are available. Patient will receive either cetuximab alone (cohort #1) or cetuximab with irinotecan (cohort #2).

Key Dates

First listed
Dec 6, 2019
Start date
Jan 7, 2020
Status verified
Jun 2023
Primary completion
Apr 30, 2024
Completion
Jul 31, 2024

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort #1
    Cetuximab monotherapy (500mg/m² IV, day 1)
  • Experimental: Cohort #2
    Cetuximab and irinotecan (cetuximab 500mg/m² IV, day 1; irinotecan 180mg/m² IV, day 1).

Primary Outcome Measure

response rate [ Time Frame: 4 months ]

Central Contacts

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