Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer

University Hospital of Crete

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: 5-FLUOROURACIL

Drug: Irinotecan

Drug: Oxaliplatin

Drug: Leukovorin

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00689624

CT/06.21

Details and patient eligibility

About

This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

Full 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 risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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