Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux® (Merck) in Metastatic Colorectal Cancer

NCT03391934 | Unknown Phase 3 DMC

• 1 other identifier: CET.CIN.HR.96 (III)
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with Erbitux® (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. 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

Conditions

Metastatic Colorectal Cancer

Keywords

RAS Wild-type; Cetuximab; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time from the date of randomization to the first date of documentation progression (per investigator assessment) or death as a result of any cause.

  PFS was measured from the start of chemotherapy to the date of disease progression or to the date of death if no progression whichever came first, assessed up to 26 weeks

Secondary Outcomes (5)

• Overall Survival (OS)

  26 weeks after study start

• Objective Response rate

  26 weeks after study start

• Time of treatment failures

  26 weeks after study start

• Adverse events

  26 weeks after study start

• immunogenicity

  26 weeks after study start

Study Arms (2)

Cetuximab+ FOLFIRI

EXPERIMENTAL

Cetuximab (Produced by CinnaGen Co.): 400 mg/m2 weekly in the first dose and 250 mg/m2 in the next doses Irinitecan: 180 mg/m2 biweekly Leucovorin: 400 mg/m2 biweekly Fluorouracil: 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly

Drug: Cetuximab + FOLFIRI

Cetuximab + FOLFIRI

ACTIVE COMPARATOR

Erbitux® (Produced by Merk Co.): 400 mg/m2 weekly Irinitecan: 180 mg/m2 biweekly Leucovorin: 400 mg/m2 biweekly Fluorouracil: 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly

Drug: Cetuximab + FOLFIRI

Interventions

Cetuximab + FOLFIRI DRUG

Cetuximab 400 mg/m2 will be administered in the first dose and 250 mg/m2 will be administered in the next doses every week. Irinotecan will be administered 180 mg/m2 biweekly. Leucovorin will be administered 400 mg/m2 biweekly.Fluorouracil will be administered 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly.

Also known as: FOLFIRI = irinotecan + calcium folinate + 5-fluorouracil

Cetuximab + FOLFIRI; Cetuximab+ FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (1)

Taleqani Hospital

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Somayeh Amini, Pharm D

CONTACT

00982143473000; amini.s@orchidpharmed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both of the drugs used in the study are indistinguishable for patients and their respective curative staff because they are similar in size and shape of the vials, caps, aluminum sealing and paints, and it is not possible to distinguish the type of brand from the appearance of the vials. Additionally, people who are evaluating the results and analyzing data are not aware of the type of patient grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: January 5, 2018
• Study Start: January 20, 2018
• Primary Completion: November 30, 2025
• Study Completion: February 1, 2026
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

IR (1)