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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

John Souglakos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/06.21

NCT ID:

NCT00689624

Start Date:

July 2007

Completion Date:

December 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Cancer
  • Cetuximab
  • FOLFOXIRI
  • Colorectal Neoplasms

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