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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colon Cancer; Colo-rectal Cancer
• Intervention / Treatment: Drug: Cetuximab nanoparticles; Drug: Oral approved anticancer drug

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71526
    • Recruiting
    • Assiut Clinic
    • Contact: Ahmed AH Abdellatif, PhD; Phone Number: +966507726856; Email: a.abdellatif@qu.edu.sa
• Saudi Arabia
  • Al Qassim
    • Buraidah, Al Qassim, Saudi Arabia, 51171
      • Recruiting
      • Buraidah Clinic
  • Qassim
    • Buraidah, Qassim, Saudi Arabia, 51452
      • Recruiting
      • Faculty of pharmacy
    • Buraidah, Qassim, Saudi Arabia, 51452
      • Recruiting
      • Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ahmed A. H. Abdellatif

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Lancet. 2015 Mar 14;385(9972):946.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): January 11, 2021

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (ACTUAL): December 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: AlAzharCetuximab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No