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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Irinotecan; Drug: Leukovorin; Drug: Oxaliplatin; Drug: 5-FLUOROURACIL; Drug: Cetuximab

• Registration Number: NCT00689624
• Lead Sponsor: University Hospital of Crete

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 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

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Leukovorin	FOLFOXIRI+Erbitux
1	Irinotecan	FOLFOXIRI+Erbitux
1	Oxaliplatin	FOLFOXIRI+Erbitux
1	5-FLUOROURACIL	FOLFOXIRI+Erbitux
1	Cetuximab	FOLFOXIRI+Erbitux

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	2 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival	1 year
Toxicity profile	Toxicity assessment on each chemotherapy cycles (every 15 days)
Pharmacogenomic analysis	During the treatment
Time to Tumor Progression	1 year
Resectability rates	Resectability at the end of treatment (4 or 6 months from the entry to the study)
Q-Twist analysis of Quality of life	Quality of life assessment every 8 weeks

Trial Locations

Locations (1)

University Hospital of Crete; 🇬🇷 Heraklion, Greece