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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab nanoparticles goup | Active Comparator | A group of volunteers infected colon cancer or colorectal cancer received cetuximab in the formulated nanoparticles |
|
| Oral approved anticancer drug | Placebo Comparator | A group of volunteers infected with colon cancer or colorectal cancer received placebo anticancer drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab nanoparticles | Drug | The active group will receive cetuximab in nanoparticles as an anti-microbial drug. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed AH Abdellatif, PhD | Contact | +966507726856 | 14618 | a.abdellatif@qu.edu.sa |
| Ahmed AH Abdellatif, PhD | Contact | +966507726856 | 2014 | ahmed.a.h.abdellatif@azhar.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut Clinic | Recruiting | Asyut | 71526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29881409 | Result | Hafez Abdellatif AA, Abdelhafez WA, Sarhan HA. Somatostatin Decorated Quantum Dots for Targeting of Somatostatin Receptors. Iran J Pharm Res. 2018 Spring;17(2):513-524. | |
| 27032509 | Result | Abdellatif AA, Zayed G, El-Bakry A, Zaky A, Saleem IY, Tawfeek HM. Novel gold nanoparticles coated with somatostatin as a potential delivery system for targeting somatostatin receptors. Drug Dev Ind Pharm. 2016 Nov;42(11):1782-91. doi: 10.3109/03639045.2016.1173052. Epub 2016 May 5. |
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| Oral approved anticancer drug | Drug | The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug. |
|
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| Buraidah Clinic | Recruiting | Buraidah | Al Qassim | 51171 | Saudi Arabia |
|
| Faculty of Pharmacy | Recruiting | Buraidah | Al-Qassim Region | 51452 | Saudi Arabia |
|
| Pharmaceutics dept., Faculty of Pharmacy, Qassim University | Recruiting | Buraidah | Al-Qassim Region | 51452 | Saudi Arabia |
|
| 25467588 | Result | Allemani C, Weir HK, Carreira H, Harewood R, Spika D, Wang XS, Bannon F, Ahn JV, Johnson CJ, Bonaventure A, Marcos-Gragera R, Stiller C, Azevedo e Silva G, Chen WQ, Ogunbiyi OJ, Rachet B, Soeberg MJ, You H, Matsuda T, Bielska-Lasota M, Storm H, Tucker TC, Coleman MP; CONCORD Working Group. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25,676,887 patients from 279 population-based registries in 67 countries (CONCORD-2). Lancet. 2015 Mar 14;385(9972):977-1010. doi: 10.1016/S0140-6736(14)62038-9. Epub 2014 Nov 26. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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