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

This study has been completed.
Sponsor:
Information provided by:
University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00689624
First received: May 29, 2008
Last updated: July 20, 2011
Last verified: September 2010
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University Hospital of Crete:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resectability rates [ Time Frame: Resectability at the end of treatment (4 or 6 months from the entry to the study) ] [ Designated as safety issue: No ]
  • Time to Tumor Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycles (every 15 days) ] [ Designated as safety issue: Yes ]
  • Pharmacogenomic analysis [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
  • Q-Twist analysis of Quality of life [ Time Frame: Quality of life assessment every 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: J.Sougklakos, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00689624     History of Changes
Other Study ID Numbers: CT/06.21
Study First Received: May 29, 2008
Last Updated: July 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by 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
Fluorouracil
Oxaliplatin
Irinotecan
Cetuximab
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014