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

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Biological: cetuximab

Drug: irinotecan hydrochloride

Drug: fluorouracil

Drug: oxaliplatin

Drug: leucovorin calcium

Study type

Interventional

Funder types

Other

Identifiers

NCT00556413

CDR0000574149

INCA-RECF0288

CLCC-ERBIRINOX

MERCK-CLCC-ERBIRINOX

EUDRACT-2005-004746-13

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)