Oxaliplatin-CPT-11-5-FU-Leucovarin + Bevacizumab and Cetuximab (OCFL-BC) as a Combination Regimen for Systemic Treatment of Advanced Colorectal Carcinoma With Potentially Resectable Liver and/or Lung Metastases. A Phase II Study
- To determine the pathological complete response (CR) rate in resected patients assessed
on lesions of less than or equal to 30 mm in size.
- To determine the clinical CR rate in all patients.
- To determine toxicity and tolerability of this regimen (pre- and postoperative
- To evaluate perioperative safety in these patients.
- To determine disease-free survival (time to progression in unresected patients) and
overall survival of the whole study population.
- To determine resectability in these patients.
- To evaluate markers that predict the occurrence of a pathological CR or a non-response
in pathological material (resected liver metastasis) and biological material collected
from these patients.
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.
Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens
Arnaud Roth, MD
Hopital Cantonal Universitaire de Geneve
United States: Federal Government