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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Safety Issue:

No

Principal Investigator

Marc Ychou, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

United States: Federal Government

Study ID:

CDR0000574149

NCT ID:

NCT00556413

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

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