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

NCT ID: NCT00689624

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-12-31

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

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

FOLFOXIRI+Erbitux

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1

Leukovorin

Intervention Type: DRUG

Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV

5-FLUOROURACIL

Intervention Type: DRUG

5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3

Cetuximab

Intervention Type: DRUG

Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

Interventions

Irinotecan

Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1

Intervention Type: DRUG

Leukovorin

Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV

Intervention Type: DRUG

5-FLUOROURACIL

5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3

Intervention Type: DRUG

Cetuximab

Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

Intervention Type: DRUG

Other Intervention Names

CPT-11; Campto; LV; LoHP; Eloxatin; 5-FU; Erbitux

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

Vassilis Georgoulias, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Souglakos, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University Hospital of Crete

Heraklion, , Greece

Countries

Greece

Other Identifiers

CT/06.21

Identifier Type: -

Identifier Source: org_study_id