Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer

Study Overview
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Brief Summary
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Due to the great toxicity of chemotherapeutic drugs to both the healthy and cancerous area, the efficient targeting could be of great benefit for a patient with advanced or metastatic tumors. Colorectal cells carry somatostatin receptors which make them a promising target for antitumor therapy since this would reduce side effects and increase drug delivery efficacy to the target site.

Detailed Description
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The investigator's aim is to deliver polymeric nanoparticles loaded with anti-cancer drug Cetuximab and decorated with somatostatin analogue in the form of oral polymeric nanoparticles, which can release at only above pH 6.8 using ethylcellulose polymer. The polymeric nanoparticles were prepared using the solvent evaporation method, further will be characterized for its drug content, size, encapsulation efficiency and drug-loading using UV spectroscopy. Moreover, the ethylcellulose nanoparticles loaded Cetuximab will release the Cetuximab at pH above 6.8, while can hold the Cetuximab at pH 1.5 which protecting the stomach from the toxicity Cetuximab. Then, the nanoparticles will target the colorectal cancer cells using octreotide, the somatostatin receptor agonist which will lead it to SSTRs overexpressed in colorectal cancer cells. The strategy of deposition of ligand will depend on using the advantage of the positive charge surface of nanoparticles which can absorb the negative charges of the targeting ligands. Final outcomes: this project will present a novel formulation for the treatment of colorectal cancer which can be delivered safely to the patients in a high dose to the affected tumor cells with reduced side effects on the other healthy cells.

Official Title
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Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue for Targeting of Colon Cancer

Conditions
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Colon Cancer, Colo-rectal Cancer

Intervention / Treatment
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* Drug: Cetuximab nanoparticles
* Drug: Oral approved anticancer drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of colon cancer Follow up and collect data for a local and systemic activity of cetuximab The systemic oral capsule of cetuximab be also given to enhance the activity as an anti-cancer activities Exclusion Criteria: Peptic ulcer Stomach disease Colon cancer

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cetuximab nanoparticles goup<br>A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles | Drug: Cetuximab nanoparticles<br>* The active group will receive cetuximab in nanoparticles as an anti-microbial drug.<br>* Other names: oral capsules;|
| Placebo Comparator: Oral approved anticancer drug<br>A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug. | Drug: Oral approved anticancer drug<br>* The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.<br>* Other names: oral capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer | Determine the bioavailability of Cetuximab after oral and intravenous administration. by measuring the peak levels of Cetuximab after 0.5 to 1.5 hours following ingestion. Determine the therapeutic window for Cetuximab after and before formulation in nanoparticles. Determine the different Cetuximab doses, peak plasma levels of Cetuximab for each formula. | one year |