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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of Crete
• Treatments: Camptothecin; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

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