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Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

NCT00755534 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2013-02-13

No results posted yet for this study

Summary

This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.

Conditions

Interventions

DRUG

Irinotecan

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

DRUG

Capecitabine

Capecitabine (p.o) 2000 mg/m2 (1000 mg/m2 x 2) on day 1-7 every 2 weeks until progression

DRUG

Cetuximab

Cetuximab(IV) 500 mg/m2 on day 1 every two weeks until progression

DRUG

Oxaliplatin

Oxaliplatin (I.V) 85 mg/m2 on day 1 every two weeks until progression

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • John Souglakos, MD · University Hospital of Crete

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Greece

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 NCT00755534 on ClinicalTrials.gov