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

Launched by CINNAGEN · Dec 31, 2017

Keywords

ClinConnect Summary

This clinical trial is comparing two medications, Cetuximab (produced by CinnaGen) and Erbitux® (made by Merck), to see which one is more effective and safe for treating metastatic colorectal cancer—this is when cancer from the colon or rectum spreads to other parts of the body. The trial specifically focuses on patients with a certain type of tumor that has a specific genetic makeup (RAS wild-type). Participants will be randomly assigned to receive either medication, and the main goal is to find out which drug helps patients live longer without their cancer getting worse.

To be eligible for this trial, participants must be 18 years or older and have a confirmed diagnosis of metastatic colorectal cancer that cannot be surgically removed. They should have measurable cancer lesions and a life expectancy of at least three months. Other health criteria related to blood counts and organ function must be met as well. Patients can expect to be closely monitored throughout the study, and it’s important to note that individuals with certain previous treatments or medical conditions may not qualify. This trial is currently recruiting participants, and it offers a chance to contribute to important research in cancer treatment.

Gender

ALL

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.