Status:
COMPLETED
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer
Lead Sponsor:
University Hospital of Crete
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
Detailed Description
The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible ris...
Eligibility Criteria
Inclusion
- Patients with histologically proven metastatic adenocarcinoma of the colon or rectum
- Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
- Patients with operable metastatic disease are excluded from the study
- Age 18-70 years
- Performance status (ECOG) 0-1
- At least one bidimensionally measurable lesion of \>= 2cm
- Life expectancy of at least 6 months
- Adequate hematologic parameters (absolute neutrophil count \>= 1.5x109/L and platelets \>=100x109/L)
- Creatinine and total bilirubin \< 1.25 times the upper limit of normal
- Aspartate and alanine aminotransferase \< 3.0 times the upper limit of normal (\<5 times in case of liver mets)
Exclusion
- Absence of active infection or malnutrition (loss of more than 20% of the body weight)
- No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
- Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
- Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
- All patients will have to sign written informed consent in order to participate in the study
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00689624
Start Date
July 1 2007
End Date
December 1 2010
Last Update
September 28 2015
Active Locations (1)
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1
University Hospital of Crete
Heraklion, Greece