Open, randomized, controlled, multicenter phase III study comparing 5-FU/FA plus irinotecan plus cetuximab versus 5-FU/FA plus irinotecan as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer. - CRYSTA

Phase 1

• Conditions: MedDRA version: 7.0Level: LLTClassification code 10052362; First-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer

• Registration Number: EUCTR2004-000137-11-CZ
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-14
• Study Completion: 2011-03-24
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Inpatient or outpatient =18 years of age
Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
Inoperable metastatic disease
Immunohistochemical evidence of epidermal growth factor receptor Expression in tumor tissue
Life expectancy of at least 12 weeks
Presence of at least 1 bi-dimensionally measurable index lesion (not lie in an irradiated area)
ECOG performance status of =2 at study entry
Effective contraception for both male and female patients if the risk of conception exists
White blood cell count =3 x 10E9/L with neutrophils =1.5 x 10E9/L, platelet count =100 x 10E9/L, hemoglobin =5.6 mmol/L (9 g/dL)
Total bilirubin =1.5 x upper reference range·
AST =2.5 x upper reference range, or =5 x upper reference range in case of liver metastasis·
Serum creatinine =1.5 x upper reference range·
Recovery from relevant toxicity to previous treatment before study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous exposure to epidermal growth factor targeting therapy
Previous irinotecan-based chemotherapy
Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated >6 months before the start of treatment in this study
Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study
Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol
Known hypersensitivity reaction to any of the components of study treatments·
Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
Brain metastasis (known or suspected)
Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia·
Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified