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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689624
First Posted: June 3, 2008
Last Update Posted: September 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vassilis Georgoulias, MD, University Hospital of Crete
  Purpose
This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: Irinotecan Drug: Leukovorin Drug: Oxaliplatin Drug: 5-FLUOROURACIL Drug: Cetuximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vassilis Georgoulias, MD, University Hospital of Crete:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 2 months ]

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

Enrollment: 30
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CPT-11
  • Campto
Drug: Leukovorin
Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
Other Name: LV
Drug: Oxaliplatin
Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
Other Names:
  • LoHP
  • Eloxatin
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 Name: 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 Name: Erbitux

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
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689624


Locations
Greece
University Hospital of Crete
Heraklion, Greece
Sponsors and Collaborators
University Hospital of Crete
Investigators
Principal Investigator: John Souglakos, MD University Hospital of Crete
  More Information

Responsible Party: Vassilis Georgoulias, MD, MD, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00689624     History of Changes
Other Study ID Numbers: CT/06.21
First Submitted: May 29, 2008
First Posted: June 3, 2008
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Vassilis Georgoulias, MD, University Hospital of Crete:
Colorectal Cancer
Cetuximab
FOLFOXIRI

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Camptothecin
Cetuximab
Fluorouracil
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs