Phase Ib Study of Drozitumab Combined With First-Line mFOLFOX6 Plus Bevacizumab in Patients with Metastatic Colorectal Cancer

• Published in: Cancer investigation Vol. 30; no. 10; pp. 727 - 731
• Main Authors: Rocha Lima, Caio M., Bayraktar, Soley, Flores, Aurea M., MacIntyre, Jessica, Montero, Alberto, Baranda, Joaquina C., Wallmark, John, Portera, Chia, Raja, Rajiv, Stern, Howard, Royer-Joo, Stephanie, Amler, Lukas C.
• Format: Journal Article
• Language: English
• Published: England Informa Healthcare 01-12-2012; Taylor & Francis
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Apo2 ligand; Apoptosis; Bevacizumab; Biomarkers, Tumor - analysis; Biomarkers, Tumor - genetics; Carcinoma - drug therapy; Carcinoma - genetics; Carcinoma - metabolism; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - genetics; Colorectal Neoplasms - metabolism; Disease-Free Survival; Drozitumab; Efficacy; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Humans; Immunohistochemistry; Leucovorin - administration & dosage; Leucovorin - adverse effects; Male; Maximum Tolerated Dose; Metastatic colorectal cancer; Middle Aged; Organoplatinum Compounds - administration & dosage; Organoplatinum Compounds - adverse effects; Toxicity
• ISSN: 0735-7907; 1532-4192
• DOI: 10.3109/07357907.2012.732163

In this multicenter phase Ib study, drozitumab was given in combination with the mFOLFOX6 regimen and bevacizumab in patients with previously untreated, locally advanced recurrent or metastatic colorectal cancer on day 1 of every 14-day cycle. Nine patients were treated at 2 different cohort dose levels of drozitumab. No dose-limiting toxicities occurred at either dose level and the maximum tolerated dose was not reached. Two patients had a partial response of 4.93 and 4.96 months duration. Cohort 2 dose level is the recommended starting dose level for future trials.