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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

NCT ID: NCT00557102

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Metastatic Cancer

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cetuximab, FOLFIRI

Group Type OTHER

cetuximab

Intervention Type BIOLOGICAL

filgrastim

Intervention Type BIOLOGICAL

fluorouracil

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

Interventions

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cetuximab

Intervention Type BIOLOGICAL

filgrastim

Intervention Type BIOLOGICAL

fluorouracil

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role collaborator

National Cancer Institute, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Marc Phelip, MD, PhD

Role: STUDY_CHAIR

University Hospital, Grenoble

Locations

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CHU de Grenoble - Hopital Michallon

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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CHUG-ERBIFORT

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0316

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-000357-54

Identifier Type: -

Identifier Source: secondary_id

CDR0000574153

Identifier Type: -

Identifier Source: org_study_id