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CompletedNCT00362102Updated Nov 22, 2016

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

A Phase 2 interventional study of Cetuximab in Colorectal Carcinoma, sponsored by Eli Lilly and Company. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Colorectal Carcinoma

Keywords

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

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 38 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subjects with symptomatic cerebral metastasis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants

Interventions

  • DrugCetuximab
06

What researchers measure

Primary outcomes

  1. Response according to the RECIST criteria accessed every 6 weeks

Secondary outcomes

  1. 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.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 18836202 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00362102
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 9, 2006
Start date
Oct 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Nov 22, 2016

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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