Overview

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

Status:
Terminated
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Treatments:
Camptothecin
Capecitabine
Cetuximab
Irinotecan
Oxaliplatin
Criteria
Inclusion Criteria:

- Histologically confirmed locally advanced or metastatic colorectal cancer

- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid
Tumors (RECIST)

- ECOG performance status ≤ 2

- Age 18 - 72 years

- Patients who have had a CR, PR or SD after 1st line therapy based on
Irinotecan+Bevacizumab

- Paraffin block from the primary tumor in order to perform tha mutational analysis of
the KRAS gene

- Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit,
ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone
marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function

- Patients must be able to understand the nature of this study

- Written informed consent

Exclusion Criteria:

- Presence of central nervous system or brain metastases

- Pregnant or lactating woman

- Life expectancy < 3 months

- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow or in the field
where the treatment target is located

- Peripheral neuropathy grade ≥2

- Known hypersensitivity to Erbitux

- Metastatic infiltration of the liver >50%

- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or
total colectomy

- Active infection

- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical
cancer

- Psychiatric illness or social situation that would preclude study compliance