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

Ahmed A. H. Abdellatif

Status and phase: Unknown; Phase 1

Conditions: Colon Cancer; Colo-rectal Cancer

Treatments: Drug: Oral approved anticancer drug; Drug: Cetuximab nanoparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT03774680

AlAzharCetuximab

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Cetuximab nanoparticles goup

Active Comparator group

Description:

A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles

Treatment:

Drug: Cetuximab nanoparticles

Oral approved anticancer drug

Placebo Comparator group

Description:

A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug.

Treatment:

Drug: Oral approved anticancer drug