Clinical trial NCT00557102: Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute, France
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Grenoble
First posted: 2007-11-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor response rate
timeFrame: From baseline to end of treatment
Secondary outcomes:
measure: Rate of resectability
timeFrame: From baseline to end of treatment
measure: Overall and disease-free survival
timeFrame: From baseline to end of treatment
measure: Tolerability
timeFrame: From baseline to end of treatment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital Michallon
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Marc Phelip, MD, PhD
role: STUDY_CHAIR
References: