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

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689624
• Other study ID #: CT/06.21
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: September 25, 2015
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Irinotecan
Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
• Leukovorin
Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
• Oxaliplatin
Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
• 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
• 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

Locations

Country	Name	City	State
Greece	University Hospital of Crete	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		2 months	No
Secondary	Resectability rates		Resectability at the end of treatment (4 or 6 months from the entry to the study)	No
Secondary	Time to Tumor Progression		1 year	No
Secondary	Overall Survival		1 year	No
Secondary	Toxicity profile		Toxicity assessment on each chemotherapy cycles (every 15 days)	Yes
Secondary	Pharmacogenomic analysis		During the treatment	No
Secondary	Q-Twist analysis of Quality of life		Quality of life assessment every 8 weeks	No