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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Carcinoma

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cetuximab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

References

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Tahara M, Shirao K, Boku N, Yamaguchi K, Komatsu Y, Inaba Y, Arai T, Mizunuma N, Satoh T, Takiuchi H, Nishina T, Sakata Y. Multicenter Phase II study of cetuximab plus irinotecan in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines. Jpn J Clin Oncol. 2008 Nov;38(11):762-9. doi: 10.1093/jjco/hyn102. Epub 2008 Oct 4.

Reference Type RESULT

PMID: 18836202 (View on PubMed)

Other Identifiers

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CA225-259

Identifier Type: -

Identifier Source: org_study_id