A Phase 2 interventional study of bevacizumab and cetuximab in Colorectal Cancer and Metastatic Cancer, sponsored by Centre Hospitalier Universitaire Vaudois. Status unknown at 4 sites in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-08-07.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and 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. Giving combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, oxaliplatin IV over 2 hours on days 1 and 15, irinotecan hydrochloride IV over 30 minutes on days 8 and 22, fluorouracil IV over 24 hours on days 1, 8, 15, and 22, leucovorin calcium IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 5 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients who are able to undergo liver resection receive bevacizumab on day 1 only of course 3 and undergo liver resection 3 weeks after chemotherapy. Beginning 4 weeks after liver resection, patients receive 2 additional courses of chemotherapy as adjuvant therapy.
Patients undergo tumor tissue and blood sample collection periodically for biological studies. Samples are analyzed for markers that predict the occurrence of a complete pathological response (pCR) or a non-response.
After completion of study treatment, patients are followed every 3 months for the first 2 years and then every 6 months thereafter.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 35 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Inclusion criteria:
Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Other serious illness or medical condition including any of the following:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
No prior chemotherapy for metastatic disease
Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens
Response as assessed by NCIC criteria
Toxicity as assessed by NCIC criteria
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois