Zaltrap (ziv-aflibercept) plus FOLFIRI is safe and efficacious for patients with advanced colorectal cancer

What's exciting about Zaltrap?

Zaltrap (ziv-aflibercept) is a monoclonal antibody that targets the vascular endothelial growth factors VEGF-A and VEGF-B, and placenta growth factor (PGF). These growth factor proteins function in pathways important for new blood vessel growth.

Recent data from the phase III VELOUR trial that combined Zaltrap with FOLFIRI demonstrated that the combination is safe and efficacious with an acceptable toxicity profile for patients with metastatic colorectal cancer including those previously treated with Avastin (bevacizumab) (Bordonaro R, et al. 2014, Taieb J, et al. 2014). Patients benefited regardless of the timing of their first progression on a first-line oxaliplatin plus Avastin containing combination (Hoff PM, et al. 2014). A phase I study showed that Zaltrap plus FOLFIRI was safe with anti-tumor activity in patients with advanced colorectal cancer (Van Cutsem E, et al. 2014).

What side effects are associated with Zaltrap?

Serious side effects from taking Zaltrap include severe or fatal bleeding and gastrointestinal perforation. Other reported side effects include diarrhea, inflammation of or sores in the mouth, fatigue, hypertension, proteinuria (protein in urine), headache, loss of appetite, weight loss, and abdominal pain (see the FDA drug label).

How can my patient get access to Zaltrap?

Zaltrap in combination with 5-FU/leucovorin, irinotecan/FOLFIRI, is FDA approved for patients with metastatic colorectal cancer that is resistant or has progressed following an oxaliplatin containing regimen (see the FDA drug label). Additionally, ongoing clinical trials are testing the safety and efficacy of other Zaltrap containing combinations. See the trials table.

 References

Summary

Name(s) Target Manufacturer Status
Zaltrap, ziv-aflibercept VEGFA, VEGFB, PGF Sanofi-Aventis FDA approved for: Colorectal Cancer

Clinical Trials

Trial Drug Status Phase
Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen [NCT01571284] Camptosar, Fluorouracil, Zaltrap, leucovorin Recruiting Phase 3
Efficacy of FOLFOX Versus FOLFOX Plus Aflibercept in K-ras Mutant Patients With Resectable Liver Metastases [NCT01646554] Eloxatin, Fluorouracil, Zaltrap, leucovorin Not yet recruiting Phase 2/Phase 3
Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer [NCT02046538] Camptosar, Eloxatin, Fluorouracil, Zaltrap, leucovorin Not yet recruiting Phase 2
Ziv-Aflibercept Followed by Ziv-Aflibercept, Fluorouracil, and Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer [NCT02235324] Fluorouracil, Zaltrap, leucovorin Not yet recruiting Phase 2
Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer [NCT01889680] Eloxatin, Fluorouracil, Zaltrap, leucovorin Not yet recruiting Phase 2
Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer [NCT02085005] Eloxatin, Xeloda, Zaltrap Not yet recruiting Phase 2
Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer [NCT01652196] Eloxatin, Fluorouracil, Zaltrap, leucovorin Recruiting Phase 2
Adjuvant Aflibercept for Metastatic Colorectal Cancer [NCT01669720] Zaltrap Recruiting Phase 2
A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer [NCT02079220] Eloxatin, Xeloda, Zaltrap Recruiting Phase 2
Phase I/II Study of Capecitabine Plus Aflibercept to Treat Metastatic Colorectal Cancer [NCT01661972] Xeloda, Zaltrap Recruiting Phase 1/Phase 2
Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas [NCT02192541] Zaltrap, ganetespib Recruiting Phase 1
MLN0128 and Ziv-Aflibercept in Treating Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery [NCT02159989] MLN0128, Zaltrap Recruiting Phase 1
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