A Phase 2 interventional study of cetuximab and filgrastim in Colorectal Cancer and Metastatic Cancer, sponsored by National Cancer Institute, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-11.
Sponsored by National Cancer Institute, France · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 24 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →National Cancer Institute, France is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Must have synchronous or metasynchronous unresectable hepatic metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Biological: cetuximab · Biological: filgrastim · Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium
Tumor response rate
Time frame: From baseline to end of treatment
Rate of resectability
Time frame: From baseline to end of treatment
Overall and disease-free survival
Time frame: From baseline to end of treatment
Tolerability
Time frame: From baseline to end of treatment
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, France