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

September 25, 2015 updated by: Vassilis Georgoulias, MD, University Hospital of Crete

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Heraklion, Greece
        • University Hospital of Crete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
FOLFOXIRI+Erbitux
Drug: Irinotecan
Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
Other Names:
  • Campto
  • CPT-11
Drug: Leukovorin
Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
Other Names:
  • LV
Drug: Oxaliplatin
Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
Other Names:
  • Eloxatin
  • LoHP
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
Other Names:
  • 5-FU
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
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: 2 months
2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Crete

Investigators

  • Principal Investigator: John Souglakos, MD, University Hospital of Crete

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/06.21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on Irinotecan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe