ERBITUX SUMMARY
ERBITUX™ (Cetuximab) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR).
ERBITUX, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.
ERBITUX (Cetuximab) administered as a single agent is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy.
The effectiveness of ERBITUX is based on objective response rates (see CLINICAL STUDIES). Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX.
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NEWS HIGHLIGHTSMedia Articles Related to Erbitux (Cetuximab)
Erbitux Recognized By ASCO As A 2009 Major Cancer Advance As First SCCHN Treatment To Improve Survival In 30 Years
Source: Ear, Nose and Throat News From Medical News Today [2009.11.18]
The American Society of Clinical Oncology (ASCO) has once again recognized Erbitux® (cetuximab) as one of the major clinical cancer advances of 2009. This year Erbitux was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with 1st-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Poniard Pharmaceuticals Announces Updated Positive Clinical Data From Phase 2 Trial Of Picoplatin In Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.18]
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC).
'Cross-talk' Mechanism Contributes To Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.14]
Researchers at the University of Wisconsin-Madison School of Medicine and Public Health have identified a molecular mechanism that allows two powerful signaling pathways to interact and begin a process leading to colorectal tumors. "We are very excited about these findings," says Vladimir Spiegelman, an associate professor of dermatology. "Drugs could be developed to block this mechanism and prevent colorectal cancer, which affects millions of people worldwide.
African-Americans With Colorectal Cancer Have Poorer Outcomes, Lower Survival Rates
Source: Colorectal Cancer News From Medical News Today [2009.11.13]
New research published in the November issue of the Journal of the American College of Surgeons shows that African-American patients with colorectal cancer are more likely to be diagnosed with advanced disease and are less likely to undergo surgical procedures compared with Caucasians, suggesting that improvements in screening and rates of operation may reduce differences in colorectal cancer outcomes for African-Americans.
Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.06]
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival.
Published Studies Related to Erbitux (Cetuximab)
A prospective randomized trial of topical pimecrolimus for cetuximab-associated acnelike eruption. [2009.10]
BACKGROUND: Clinical trials addressing the acneiform rash associated with epidermal growth factor receptor inhibitors are lacking. OBJECTIVE: We evaluated the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash... CONCLUSIONS: Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.
Radiological tumor size decrease at week 6 is a potent predictor of outcome in chemorefractory metastatic colorectal cancer treated with cetuximab (BOND trial). [2009.08]
BACKGROUND: Early radiological tumor shrinkage may be associated with better long-term outcome in chemorefractory metastatic colorectal cancer (cmCRC) treated with cetuximab. We aimed at validating this in a large and independent series... CONCLUSIONS: Tumor shrinkage at 6 weeks is a strong predictor of TTP and OS in cmCRC patients treated with cetuximab with or without irinotecan. This suggests early tumor shrinkage is the hallmark of efficacy of cetuximab and reliably identifies the subpopulation that is sensitive to the drug. Early tumor shrinkage can be used as a marker of efficacy in clinical practice, as such or in combination.
A randomized, phase II trial of two dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer (NSCLC). [2009.06]
BACKGROUND: This trial investigated the efficacy and safety of weekly cetuximab combined with two different schedules of paclitaxel/carboplatin for stage IIIB/IV non-small-cell lung cancer (NSCLC)... CONCLUSIONS: This study did not meet the prespecified benchmark of 35% 6-month PFS rate; both combination schedules of cetuximab plus paclitaxel/carboplatin were feasible and equivalent for treating advanced NSCLC.
[Efficacy of cetuximab in therapy of metastatic colorectal cancer: a system evaluation] [2009.05.26]
OBJECTIVE: To assess the clinical efficacy of cetuximab in the treatment of individuals with metastatic colorectal cancer... CONCLUSION: Cetuximab in combination with chemotherapy has promising efficacy in the therapy of metastatic colorectal cancer, and status of gene KRAS is an independent predictive marker for response of cetuximab.
Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. [2009.05.02]
BACKGROUND: Use of cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), has the potential to increase survival in patients with advanced non-small-cell lung cancer. We therefore compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFR-positive non-small-cell lung cancer... INTERPRETATION: Addition of cetuximab to platinum-based chemotherapy represents a new treatment option for patients with advanced non-small-cell lung cancer. FUNDING: Merck KGaA.
Clinical Trials Related to Erbitux (Cetuximab)
Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer [Active, not recruiting]
The purpose of the study is to determine in patients with Non Small Cell Lung Cancer
refractory to previous chemotherapy whether concomitant treatment with cetuximab and
pemetrexed improves progression-free survival compared with cetuximab monotherapy.
Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer [Active, not recruiting]
The purpose of this study is to determine if the addition of a unique targeted agent called
Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard
treatment with chemotherapy and radiation.
Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Pancreatic Cancer [Suspended]
Eligible patients with pancreatic cancer will be treated with dual agent monoclonal antibody
consisting of cetuximab and bevacizumab alone or in combination with gemcitabine
Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors [Completed]
The purpose of this clinical research study is to establish the maximum tolerated dose and
recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and
adolescent patients with refractory solid tumors.
FLOX in Combination With Cetuximab in First-Line Treatment of Colorectal Cancer [Active, not recruiting]
The main objective of this trial is to explore the effect of combining an established
chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin
(Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of
metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab,
in which FLOX is given continuously or intermittently, compared to standard FLOX without
cetuximab.
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