Status:
RECRUITING
Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux® (Merck) in Metastatic Colorectal Cancer
Lead Sponsor:
Cinnagen
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT03391934
Start Date
January 20 2018
End Date
February 1 2026
Last Update
April 5 2023
Active Locations (1)
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1
Taleqani Hospital
Tehran, Iran