An equivalency clinical trial to determine the efficacy and safety between Cetuximab (produced by CinnaGen) compared with Erbitux® in RAS wild-type Metastatic Colorectal Cancer

Phase 3

Recruiting

Conditions: RAS wild-type Metastatic Colorectal Cancer.
Malignant neoplasm of colon, Malignant neoplasm of rectum
C18.9, C20

Registration Number: IRCT2017110821315N10

Lead Sponsor: CinnaGen company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 234

Inclusion Criteria

male or female
Age of 18 till 75
histologically confirmed adenocarcinoma of the colon or rectum
having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
metastatic disease that could not be resected for curative purposes
immunohistochemical evidence of tumor EGFR expression (expanded wild-type RAS)
Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
life expectancy of longer than 3 months (by clinical assessment)
adequate organ and marrow function.

Exclusion Criteria

Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy
the use of 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 a history of another primary malignancy in less than 5 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 chemically or biologically similar to Cetuximab, irinotecan, 5-FU 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
Subjects with known infection with HIV, HBV, HCV
first line treatment in patient with right sided primary tumor

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Progression-Free Survival (PFS) time of Cetuximab and Erbitux®. Timepoint: a 12-month period. Method of measurement: 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.

Secondary Outcome Measures