Status:
TERMINATED
Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief 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 oxalipl...
Detailed Description
Because of the recent advances in the field of systemic chemotherapy for mCRC, like irinotecan, oxaliplatin, capecitabine, and targeted agents (Cetuximab, Bevacizumab) mCRC patients have an overall su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00755534
Start Date
November 1 2008
End Date
November 1 2008
Last Update
February 13 2013
Active Locations (10)
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1
University Hospital of Heraklion, Dep of Medical Oncology
Heraklion, Crete, Greece
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
401 Military Hospital of Athens
Athens, Greece