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

A Multi-center, Open Label, Non-randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-detectable Metastatic Colorectal Carcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362102

Enrollment

Registered

2006-08-09

Start date

2005-10-31

Completion date

2006-07-31

Last updated

2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma

Keywords

EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure

Brief summary

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.

Interventions

DRUGCetuximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response according to the RECIST criteria accessed every 6 weeks	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026