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

NCT00689624 | Completed Phase 2

• 1 other identifier: CT/06.21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Cetuximab; FOLFOXIRI

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  2 months

Secondary Outcomes (6)

• Resectability rates

  Resectability at the end of treatment (4 or 6 months from the entry to the study)

• Time to Tumor Progression

  1 year

• Overall Survival

  1 year

• Toxicity profile

  Toxicity assessment on each chemotherapy cycles (every 15 days)

• Pharmacogenomic analysis

  During the treatment

Study Arms (1)

1

EXPERIMENTAL

FOLFOXIRI+Erbitux

Drug: Irinotecan; Drug: Leukovorin; Drug: Oxaliplatin; Drug: 5-FLUOROURACIL; Drug: Cetuximab

Interventions

Irinotecan DRUG

Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1

Also known as: CPT-11, Campto

1

Leukovorin DRUG

Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3

Also known as: LV

1

Oxaliplatin DRUG

Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV

Also known as: LoHP, Eloxatin

1

5-FLUOROURACIL DRUG

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

Also known as: 5-FU

1

Cetuximab DRUG

Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

Also known as: Erbitux

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (1)

University Hospital of Crete

Heraklion, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Leucovorin; Oxaliplatin; Fluorouracil; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John Souglakos, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

GR (1)