Comparing two treatments for metastatic colorectal cancer

A Phase III, Randomized, Two-armed, Parallel, Double-blind, Active-controlled, Equivalency Clinical Trial of Cetuximab (CinnaGen Co.) Efficacy and Safety Compared With Erbitux (Merck Co.) and FOLFIRI for RAS Wild-type mCRC

This study is testing if a new version of a cancer drug called Cetuximab works as well as the established drug Erbitux for people with metastatic colorectal cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cinnagen (Industry-sponsored)
• Drugs / interventions: cetuximab, chemotherapy
• Locations: 1 site (Tehran)
• Trial ID: NCT03391934 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial is designed to compare the efficacy and safety of Cetuximab produced by CinnaGen against the reference drug Erbitux in patients with RAS wild-type metastatic colorectal cancer. The study employs a randomized, double-blind, active-controlled design with a primary endpoint of Progression-Free Survival. Eligible participants will be randomly assigned to receive either treatment, with specific inclusion and exclusion criteria to ensure appropriate patient selection. The trial aims to determine if the CinnaGen version of Cetuximab is as effective as the established Erbitux.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically confirmed metastatic adenocarcinoma of the colon or rectum and specific measurable tumor characteristics.

Not a fit: Patients who have previously received anti-EGFR therapy or irinotecan-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment option for patients with metastatic colorectal cancer.

How similar studies have performed: Other studies have shown success with similar approaches in comparing different formulations of Cetuximab, indicating this study builds on established research.

Eligibility criteria

Inclusion Criteria:

* Male or female older than 18 years old
* Histologically confirmed adenocarcinoma of the colon or rectum which is metastatic
* Having one or more bi-dimensionally measurable lesions as defined by RECIST criteria
* Tumor that could not be resected for curative purposes
* ECOG performance status score of 2 or less
* Life expectancy of longer than 3 months (clinical assessment)
* Evidence of tumor EGFR expression (expanded wild-type RAS)
* Adequate organ and marrow function as defined:

ANC ≥ 1,500/mm3 Plt ≥ 100,000/mm3 Hb ≥ 9 g/dL (may have had blood transfusions) AST/ALT ≤ 2.5 IULN or ≤ 5 IULN with known liver metastases Total bilirubin ≤ 1.5 IULN Serum Creatinine ≤ 1.5 IULN INR ≤ 1.5 and PTT ≤ 1.5 IULN

Exclusion Criteria:

* Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy
* Radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial
* Female patients who are pregnant or lactating
* Patients with any history of another primary malignancy in the past five years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
* Patients with history of allergic reactions attributed to compounds of similar chemical or biologic drugs as cetuximab, irinotecan, fluorouracil or leucovorin
* Adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial
* Inability to comply with study and/or follow-up procedures.

Where this trial is running

Tehran

• Taleqani Hospital — Tehran, Iran, Islamic Republic of (Recruiting)

Study contacts

• Study coordinator: Somayeh Amini, Pharm D

Conditions Metastatic Colorectal Cancer; RAS Wild-type; Cetuximab