A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma

Eli Lilly and Company38 enrolled

Overview

To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Carcinoma

Interventions

CetuximabDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject must have surgically unresectable metastatic colorectal carcinoma. * The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy * ECOG PS 0-2 Exclusion Criteria: * Subjects with symptomatic cerebral metastasis

Outcomes

Primary Outcomes

Response according to the RECIST criteria accessed every 6 weeks

Secondary Outcomes

Time to progression, duration of achieved response, and the disease control rate will be accessed in all patients who received Cetuximab. The worst toxicity grades per patients will be tabulated for adverse events and laboratory measurements.

Data from ClinicalTrials.gov

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