RAS wild-type Metastatic Colorectal Cancer. Malignant neoplasm of colon, Malignant neoplasm of rectum
Conditions
Interventions
Intervention 1: CinnaGen Cetuximab (produced by CinnaGen) 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months. Intervention 2: Erbitux® 400 mg/m2
Sponsors
CinnaGen company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Overall survival. Timepoint: a 12-month period. Method of measurement: the time from date of randomization to date of death due to any cause.;Objective response rate. Timepoint: a 12-month period. Method of measurement: RECIST criteria (Response Evaluation Criteria in Solid Tumors).;Time to treatment failure. Timepoint: a 12-month period. Method of measurement: - Time of treatment failures define as the time from the date of randomization to the date of each of the following, - The treatment modalities did not destroy or modify the cancer cell. - The tumor either became larger (disease progression) or stayed the same size after treatment, - Death from any cause - Discontinuation of treatment.;Safety and frequency of AEs. Timepoint: a 12-month period. Method of measurement: Safety wills assess on the basis of reports of adverse events, laboratory-test results, and vital sign measurements.;Immunogenicity. Timepoint: Weeks 1, 2, 4, 10, 16, 22, 28, 34, 40 and 46. Method of measurement: assessment (antidrug antibody [ADA] and neutralizing antibody [nAb]). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed company
Outcome results
None listed