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

Colorectal Cancer Clinical Trial

Official title:

Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556413
• Other study ID #: CDR0000574149
• Secondary ID: CLCC-ERBIRINOXIN
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: November 17, 2011

Study information

• Verified date: February 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Determine the complete response rate in patients with metastatic colorectal cancer treated with cetuximab and FOLFIRINOX chemotherapy comprising oxaliplatin, irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.

Secondary

• Determine the objective response rate in patients treated with this regimen.

• Assess the tolerability of this regimen in these patients.

• Determine the time to response and time to progression in patients treated with this regimen.

• Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1 and 8. Patients also receive FOLFIRINOX chemotherapy comprising oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 30-90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 17, 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• cetuximab

Drug:
• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		6 months
Secondary	Objective response rate		6 months
Secondary	Adverse events by using NCI-CTC		6 months
Secondary	Time to response		6 months
Secondary	Time to progression		6 months
Secondary	Survival		6 months