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

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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