A Clinical Trial to Determine the Therapeutic Efficacy and Safety Between Cetuximab® (Produced by CinnaGen) and FOLFIRI Compared With Erbitux® (Cetuximab, Produced by Merck Company) and FOLFIRI for RAS Wild-type Metastatic Colorectal Cancer Patien

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cinnagen
• Treatments: Cetuximab; Fluorouracil; Irinotecan; Leucovorin

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.