Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT02316496
Phase
PHASE2
Status
Terminated

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • cetuximab — DRUG
    cetuximab 500mg/m²/ IV infusion, (q2w)
  • Irinotecan — DRUG
    Irinotecan 180mg/m², in 500ml NaCl 0.9% solution, 90 min IV infusion (q2w)

Study Details

The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer. Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

Key Dates

Start date
Sep 23, 2015
Status verified
Jan 2017
Primary completion
Jan 31, 2016
Completion
Jan 31, 2017

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: open label , single arm
    cetuximab - irinotecan until progression or unacceptable toxicity

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: At 2 months ]

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