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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

Thank you

Trial Information

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



- 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.


- 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

Inclusion Criteria


- 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


- 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

- No severe unstable angina

- No symptomatic heart failure

- No other concurrent illness


- At least 3 months since prior adjuvant anticancer chemotherapy

- No concurrent participation in another clinical trial

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Time Frame:

From baseline to end of treatment

Safety Issue:


Principal Investigator

Jean Marc Phelip, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital, Grenoble


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

September 2007

Completion Date:

December 2010

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • 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
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary