Colon Cancer, Colo-rectal Cancer
Conditions
Brief summary
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
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.
Interventions
DRUGCetuximab nanoparticles
The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
DRUGOral approved anticancer drug
The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
Sponsors
Ahmed A. H. Abdellatif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of pharmacokinetics parameters of Cetuximab for targeted colon cancer | one year | 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. |
Countries
Egypt, Saudi Arabia
Contacts
Primary ContactAhmed AH Abdellatif, PhD
Backup ContactAhmed AH Abdellatif, PhD
Outcome results
None listed