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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

cetuximab

fluorouracil

irinotecan hydrochloride

leucovorin calcium

oxaliplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERBIRINOX

Arm Description

5FU + Irinotecan + Oxaliplatine + Cetuximab

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

Objective response rate

Adverse events by using NCI-CTC

Time to response

Time to progression

Survival

Full Information

NCT ID

NCT00556413

First Posted

November 9, 2007

Last Updated

February 17, 2021

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

1. Study Identification

Unique Protocol Identification Number

NCT00556413

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

November 17, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ERBIRINOX

Arm Type

Experimental

Arm Description

5FU + Irinotecan + Oxaliplatine + Cetuximab

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Type

Drug

Intervention Name(s)

leucovorin calcium

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Primary Outcome Measure Information:

Title

Complete response rate

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Objective response rate

Time Frame

6 months

Title

Adverse events by using NCI-CTC

Time Frame

6 months

Title

Time to response

Time Frame

6 months

Title

Time to progression

Time Frame

6 months

Title

Survival

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Ychou, MD, PhD

Organizational Affiliation

Institut du Cancer de Montpellier - Val d'Aurelle

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Montpellier

ZIP/Postal Code

34298

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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