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

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00755534
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 72 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
  • Capecitabine — DRUG
    Capecitabine (p.o) 2000 mg/m2 (1000 mg/m2 x 2) on day 1-7 every 2 weeks until progression
  • Cetuximab — DRUG
    Cetuximab(IV) 500 mg/m2 on day 1 every two weeks until progression
  • Oxaliplatin — DRUG
    Oxaliplatin (I.V) 85 mg/m2 on day 1 every two weeks until progression

Study Details

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.

Key Dates

Start date
Nov 30, 2008
Status verified
Feb 2013
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008

Study Design

Enrollment
68 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Irinotecan+Erbitux -\> XELOX+Erbitux
  • Experimental: 2
    XELOX+Erbitux -\>Irinotecan+Erbitux

Primary Outcome Measure

Time To Progression [ Time Frame: 1 year ]

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