Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

NCT00556413 | Completed Phase 2

• 5 other identifiers: CDR0000574149CLCC-ERBIRINOXINCA-RECF0288EUDRACT-2005-004746-13MERCK-CLCC-ERBIRINOX
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  6 months

Secondary Outcomes (5)

• Objective response rate

  6 months

• Adverse events by using NCI-CTC

  6 months

• Time to response

  6 months

• Time to progression

  6 months

• Survival

  6 months

Study Arms (1)

ERBIRINOX

EXPERIMENTAL

5FU + Irinotecan + Oxaliplatine + Cetuximab

Biological: cetuximab; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin

Interventions

cetuximab BIOLOGICAL

ERBIRINOX

fluorouracil DRUG

ERBIRINOX

irinotecan hydrochloride DRUG

ERBIRINOX

leucovorin calcium DRUG

ERBIRINOX

oxaliplatin DRUG

ERBIRINOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Metastatic, unresectable disease * May or may not express the EGFR gene * Measurable disease, defined as ≥ 1 measurable lesion by MRI or CT scan * Lesion must be outside an irradiated area PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy \> 3 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Transaminases ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present) * Creatinine ≤ 1.5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No peripheral or symptomatic neuropathy ≥ grade 2 (NCI-CTCAE) * No complete or partial intestinal blockage * No intestinal inflammatory disease (e.g., Crohn's disease or ulcerative colitis) * No chronic diarrhea * No severe unstable cardiac disease (despite treatment) * No myocardial infarction within the past 6 months * No neurological or psychiatric illness, including epilepsy or dementia * No uncontrolled active infection * No other prior or concurrent malignancy within the past 5 years except for curatively treated basal cell skin cancer * No psychological, familial, social, or geographic reason that would preclude study follow-up PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease * Prior fluorouracil-based adjuvant chemotherapy allowed provided it was administered ≥ 4 weeks ago * At least 4 weeks since prior and no other concurrent experimental therapy * No prior irinotecan hydrochloride, oxaliplatin, or monoclonal antibody * No prior intestinal resection (e.g., hemicolectomy or extended resection of the small intestine)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

• Assenat E, Desseigne F, Thezenas S, Viret F, Mineur L, Kramar A, Samalin E, Portales F, Bibeau F, Crapez-Lopez E, Bleuse JP, Ychou M. Cetuximab plus FOLFIRINOX (ERBIRINOX) as first-line treatment for unresectable metastatic colorectal cancer: a phase II trial. Oncologist. 2011;16(11):1557-64. doi: 10.1634/theoncologist.2011-0141. Epub 2011 Oct 20.

  PMID: 22016477 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

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)

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

Study Officials

• Marc Ychou, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: September 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: November 17, 2011
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

FR (1)