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

NCT02316496 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-08-01

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

cetuximab

cetuximab 500mg/m²/ IV infusion, (q2w)

DRUG

Irinotecan

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

Sponsors & Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Jean Marc GORNET, MD · Hôpital Saint Louis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-23
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316496 on ClinicalTrials.gov