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

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 le...

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Bibliographic Details
Published in:Cancer investigation 2012-12, Vol.30 (10), p.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: Article
Language:English
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
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Description
Summary: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.
ISSN:0735-7907
1532-4192
DOI:10.3109/07357907.2012.732163