Lohp, 5-Fu/Lv and Bevacizumab, Alternative With Cpt-11, 5-Fu/Lv and Cetuximab In Metastatic Crc

Sponsor
University Hospital of Crete
Study ID
NCT00755118
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Oxaliplatin — DRUG
    Oxaliplatin (I.V) 85mg/m2 on week 1 and week 3 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
  • 5-Fluorouracil — DRUG
    5-Fluorouracil (I.V) 1750mg/m2 on week 1,2,3 and 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
  • Leucovorin — DRUG
    Leucovorin (I.V) 500mg/m2 on week 1,2,3 and 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
  • Bevacizumab — DRUG
    Bevacizumab (I.V) 10mg/Kg on week 1 and week 3 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
  • Irinotecan — DRUG
    Irinotecan (I.V) 110mg/m2 on week 2 and week 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity
  • Cetuximab — DRUG
    Cetuximab (I.V) 500mg/m2 on week 2 and week 4 every six weeks for 2 continuously until disease progression or the appearance of unacceptable toxicity

Study Details

The aim of this study is to evaluate the efficacy of the effective drugs in a alternating chemotherapy schedules in pretreated patients with mCRC, who have received all effective drugs.

Key Dates

Start date
Oct 31, 2008
Status verified
Oct 2015
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    LoHP/AIO/Avastin-\>CPT-11/AIO/Erbitux

Primary Outcome Measure

Objective Response Rate [ Time Frame: 3 - 6 month ]

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