Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00681876
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
  • Avastin — DRUG
    Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
  • Erbitux — DRUG
    Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Study Details

This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.

Key Dates

Start date
Apr 30, 2008
Status verified
Feb 2013
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Irinotecan+Avastin+Erbitux

Primary Outcome Measure

Time To Progression [ Time Frame: 1 year ]

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