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Irinotecan, Cetuximab and Everolimus to Patients With Metastatic Colorectal Cancer

NCT01387880 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-03-20

No results posted yet for this study

Summary

This is an open, multicenter phase II trial of therapy with a combination of cetuximab, and irinotecan every second week combined with a daily dose of everolimus to patients with metastatic colorectal cancer with Kirsten rat sarcoma viral oncogene (KRAS) mutation or to patients resistent to cetuximab and irinotecan therapy for metastatic colorectal cancer.

Conditions

Interventions

DRUG

Everolimus

Patients with KRAS mutant tumours are treated with cetuximab, everolimus and irinotecan as third line. Patients with KRAS wildtype tumours that have progressed on therapy with cetuximab and irinotecan are treated with cetuximab, everolimus and Irinotecan.

DRUG

Everolimus

1.66 mg per day up to 7½ mg per day

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Benny V Jensen, MD · University of Copenhagen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-11-30
Completion
2012-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

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 NCT01387880 on ClinicalTrials.gov