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Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung (ERBIFORT)

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

cetuximab

filgrastim

fluorouracil

irinotecan hydrochloride

leucovorin calcium

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, lung metastases, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the colon or rectum
Must have synchronous or metasynchronous unresectable hepatic metastases
- Less than 8 hepatic metastases
- Less than 6 segments of liver involvement with metastases
No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases
Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible
At least 1 measurable metastasis by CT scan or MRI
No brain metastases, bone metastases, or carcinomatous meningitis
No celiac lymph node involvement or peritoneal cancer

PATIENT CHARACTERISTICS:

WHO performance status 0-1
Life expectancy > 3 months
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
PT rate > 70%
Bilirubin < 30 μmol/L
Creatinine < 130 μmol/L
Creatinine clearance > 60 mL/min
Not pregnant or nursing
No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
No severe unstable angina
No symptomatic heart failure
No other concurrent illness

PRIOR CONCURRENT THERAPY:

At least 3 months since prior adjuvant anticancer chemotherapy
No concurrent participation in another clinical trial

Sites / Locations

CHU de Grenoble - Hopital Michallon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cetuximab, FOLFIRI

Arm Description

Outcomes

Primary Outcome Measures

Tumor response rate

Secondary Outcome Measures

Rate of resectability

Overall and disease-free survival

Tolerability

Full Information

NCT ID

NCT00557102

First Posted

November 9, 2007

Last Updated

December 10, 2012

Sponsor

National Cancer Institute, France

Collaborators

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT00557102

Brief Title

Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung

Acronym

ERBIFORT

Official Title

Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, France

Collaborators

University Hospital, Grenoble

4. Oversight

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, such as irinotecan, leucovorin, and fluorouracil, 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 colorectal cancer that has spread to the liver and/or lung.

Detailed Description

OBJECTIVES: Primary Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy. Secondary Determine the rate of resectability in patients treated with this regimen. Determine the overall and disease-free survival of patients treated with this regimen. Determine the tolerability of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI chemotherapy, patients with responding disease undergo surgical resection of visceral metastases.

6. Conditions and Keywords

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

Colorectal Cancer, Metastatic Cancer

Keywords

liver metastases, lung metastases, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cetuximab, FOLFIRI

Arm Type

Other

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Type

Drug

Intervention Name(s)

leucovorin calcium

Primary Outcome Measure Information:

Title

Tumor response rate

Time Frame

From baseline to end of treatment

Secondary Outcome Measure Information:

Title

Rate of resectability

Time Frame

From baseline to end of treatment

Title

Overall and disease-free survival

Time Frame

From baseline to end of treatment

Title

Tolerability

Time Frame

From baseline to end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Must have synchronous or metasynchronous unresectable hepatic metastases Less than 8 hepatic metastases Less than 6 segments of liver involvement with metastases No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible At least 1 measurable metastasis by CT scan or MRI No brain metastases, bone metastases, or carcinomatous meningitis No celiac lymph node involvement or peritoneal cancer PATIENT CHARACTERISTICS: WHO performance status 0-1 Life expectancy > 3 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ PT rate > 70% Bilirubin < 30 μmol/L Creatinine < 130 μmol/L Creatinine clearance > 60 mL/min Not pregnant or nursing No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No severe unstable angina No symptomatic heart failure No other concurrent illness PRIOR CONCURRENT THERAPY: At least 3 months since prior adjuvant anticancer chemotherapy No concurrent participation in another clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Marc Phelip, MD, PhD

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Study Chair

Facility Information:

Facility Name

CHU de Grenoble - Hopital Michallon

City

Grenoble

ZIP/Postal Code

38043

Country

France

12. IPD Sharing Statement

Learn more about this trial

Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung

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