WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, COMPROMISED WOUND HEALING
Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received ZALTRAP in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer ZALTRAP to patients with severe hemorrhage [ see Dosage and Administration, Warnings and Precautions
].
Gastrointestinal Perforation: Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving ZALTRAP. Discontinue ZALTRAP therapy in patients who experience GI perforation [ see Dosage and Administration, Warnings and Precautions
].
Compromised Wound Healing: Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume ZALTRAP for at least 4 weeks following major surgery and until the surgical wound is fully healed [ see Dosage and Administration, Warnings and Precautions
].
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ZALTRAP SUMMARY
Ziv-aflibercept is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa.
ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen [see Clinical Studies].
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NEWS HIGHLIGHTS
Published Studies Related to Zaltrap (Aflibercept)
Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. [2012]
Bayer HealthCare, Berlin, Germany) with monthly ranibizumab... CONCLUSIONS: Intravitreal aflibercept dosed monthly or every 2 months after 3
Safety and Efficacy of Combined Yttrium 90 Resin Radioembolization with
Aflibercept and FOLFIRI in a Patient with Metastatic Colorectal Cancer. [2015]
Background. When associated with isolated four or fewer liver foci, metastatic
colorectal cancer is amenable to surgical resection... An ongoing randomized clinical trial aims to define the role of combined
targeted therapy and chemotherapy with radioembolization with Y90.
Systemic levels of vascular endothelial growth factor before and after
intravitreal injection of aflibercept or ranibizumab in patients with age-related
macular degeneration: a randomised, prospective trial. [2015]
patients with exudative age-related macular degeneration (AMD)... CONCLUSION: After intravitreal aflibercept injection, the systemic VEGF levels
Aflibercept treatment for patients with exudative age-related macular
degeneration who were incomplete responders to multiple ranibizumab injections
(TURF trial). [2014]
patients with recalcitrant exudative age-related macular degeneration (AMD)... CONCLUSIONS: Aflibercept 2.0 mg treatment maintained mean visual acuity
Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan
with and without ziv-aflibercept in patients with platinum-treated small-cell
lung cancer. [2014]
clinical setting... CONCLUSION: Ziv-aflibercept improved the 3-month PFS in patients who had
Clinical Trials Related to Zaltrap (Aflibercept)
Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection [Recruiting]
Background/aims: Aflibercept is an approved therapy for neovascular macular degeneration
(AMD), diabetic macular edema (DME), retinal vein occlusion and other retinal conditions.
Ziv-aflibercept is also approved by FDA and is extremely cost-effective relative to the
expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to
the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept.
Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes
over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous
saving compared to aflibercept or ranibizumab. Phase I studies and case reports did not
report any untoward toxic effects but attested to the clinical efficacy of the medication.
Our purpose is to ascertain the long-term safety and efficacy in various retinal diseases of
intravitreal ziv-aflibercept.
Methods: Prospectively, consecutive patients with retinal disease that require aflibercept
(AMD, DME, RVO, and others) will undergo instead the same molecule ziv-aflibercept
intravitreal injection of 0. 05 ml of fresh filtered ziv-aflibercept (1. 25mg). Monitoring of
best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal
structure by spectral domain OCT to be done initially, one month, 6 months, 1 year, and 2
years after injections.
Anticipated Results: Analyze signs of retinal toxicity, intraocular inflammation, or change
in lens status, together with best corrected visual acuity and central foveal thickness at 1
month, 6 months, 1 year and 2 year. Anticipated Conclusions: Off label use of
ziv-aflibercept improves visual acuity without ocular toxicity and offers a cheaper
alternative to the same molecule aflibercept (or lucentis), especially in the third world
similar to bevacizumab.
VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer [Completed]
This phase I/II trial is studying the side effects and best dose of VEGF Trap when given
together with docetaxel and to see how well they work in treating patients with persistent
or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used
in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving VEGF Trap
together with docetaxel may kill more tumor cells
Intravitreal Aflibercept in Neovascular AMD With Limited Response to Ranibizumab [Completed]
Title: Intravitreal aflibercept (VEGF Trap-Eye) in neovascular age-related macular
degeneration with limited response to ranibizumab
Purpose: The purpose of this investigator initiated study is to identify the duration of
treatment effects of intravitreal aflibercept on sub- and intraretinal fluid and best
corrected visual acuity (BCVA) in choroidal neovascularizations (CNV) due to age-related
macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment
interval failed to be extended to 6 weeks intervals in a treat and extend regimen.
Objectives: The primary objective is to evaluate the mean maximum recurrence-free treatment
interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid (for
explanation see section Objectives). The individual maximum recurrence-free treatment
interval (in weeks) at 24 weeks is defined as the maximum extension interval which is
reached during the study follow-up period without showing any CNV activity (any intra-or
subretinal fluid at OCT or new retinal hemorrhage). This measure reflects the duration of
aflibercept effect in these lesions with limited response to ranibizumab. Key secondary
Outcome Measures are mean changes in BCVA score at 24 weeks from baseline (Δ BCVAscore),
mean changes in CRT (µm) at 24 weeks from baseline (Δ CRT), mean number of treatments needed
during the 24 weeks study follow-up, number of participants with adverse events and serious
adverse events (for further outcome measures see section Objectives).
Population: This outpatient study population will consist of a representative group of 33
male and female patients ≥ 50 years of age. The study population will include patients with
subfoveal CNV secondary to AMD and being pre-treated with intravitreal ranibizumab in a
treat and extend regimen and failed to be extended to 6-weeks intervals without showing CNV
activity (for further information see section Criteria).
Interventions: 1-arm interventional study with 2mg aflibercept intravitreally up to
4-weekly. The first treatment interval with aflibercept will be 4 weeks and corresponding to
the treat and extend regime intervals will be increased in 2-weeks-steps as long as no CNV
activity (any intra-or subretinal fluid at OCT or new retinal hemorrhage) occurs. In case of
occuring CNV activity the interval is shortened by 4 weeks with a minimum treatment interval
of 4 weeks.
Intravitreal Aflibercept Injection for Radiation Retinopathy [Active, not recruiting]
The purpose of this study is to assess the safety of intravitreal aflibercept injection - in
the treatment of macular edema associated with retinopathy secondary to previous radiation
therapy.
Laser Therapy Combined With Intravitreal Aflibercept vs Intravitreal Aflibercept Monotherapy (LADAMO) [Recruiting]
This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of
laser therapy to areas of peripheral retinal ischaemia combined with intravitreal
aflibercept versus intravitreal aflibercept monotherapy. Both arms will have 2mg
intravitreal aflibercept according to a treat and extend protocol.
The specific aim of the study is to test whether laser therapy of peripheral retinal
ischaemia reduces the overall number of intravitreal aflibercept injections required to
control DMO over a 24 month period.
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Page last updated: 2015-08-10
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