A randomized, open-label phase II studyevaluating the efficacy and safety of FOLFOX-4plus cetuximab versus UFOX plus cetuximab asfirst-line therapy in subjects with metastaticcolorectal cancer - FUTURE

• Conditions: Metastatic colorectal cancer; MedDRA version: 8.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2006-000685-36-AT
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-23
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Both male and female subjects are eligible for randomization.
For inclusion in the study, all of the following inclusion criteria must be fulfilled:
•Subject has given written informed consent before any study-related activities are carried out
•Inpatient or outpatient =18 years of age
•Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum
•First occurrence of metastatic disease (at presentation not curatively resectable)
•Presence of at least one lesion unidimensionally measurable by CT- and/or MRI-scans. (target lesion(s) must not lie within an irradiated area)
•Life expectancy of =3 months
•Karnofsky performance status of =60 at study entry
•White blood cell count (WBC) =3 x 10^9/L, with neutrophils =1.5 x 10^9/L, platelets =100 x 10^9/L, and hemoglobin =9 g/dL
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal range (ULN) (<5 x ULN if liver metastasis are present)
•Normal serum creatinine (in case of elevated creatinine, labeled EDTA (ethylenediaminetetraacetic acid) clearance =65mL/min is acceptable)
•Effective contraception for both male and female subjects if the risk of conception exists
•Tumor biopsy or archived tumor sample available

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

Subjects are not eligible for this study if they fulfill one or more of the following exclusion criteria:
•Brain metastasis and/or leptomeningeal disease (known or suspected)
•Previous chemotherapy for CRC except adjuvant treatment with progression of disease documented >6 months after end of adjuvant treatment
•Previous oxaliplatin-based chemotherapy
•Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization
•Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-VEGF therapy, or EGFR-pathway targeting therapy not indicated in the study protocol
•Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception
•Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
•Peripheral neuropathy >grade 1
•Known hypersensitivity reaction to any of the components of the treatment
•Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix (subjects with a previous malignancy but without evidence of disease for =5 years will be allowed to enter the study)
•Pregnancy (absence to be confirmed by beta-human choriongonadotrophin [ß-hCG] test) or lactation period
•Known drug abuse/alcohol abuse
•Legal incapacity or limited legal capacity
•Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
•Participation in another clinical study within the 30 days before randomization
•Significant disease which, in the investigator’s opinion, would exclude the subject from the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the PFS in subjects receiving cetuximab plus either UFOX or FOLFOX-4 as initial treatment for metastatic colorectal cancer.;Secondary Objective: The secondary objectives of this study include the assessment and comparison of:<br>•Response rate (the sum of CR rate and PR rate) in each treatment group<br>•OS in each treatment group<br>•Safety <br>•Quality of Life (QOL), assessed by Functional Assessment of Cancer Therapy–Colorectal (FACT-C), and Euro-QOL (EQ-5D) at each site where appropriate translations of the questionnaires are available and validated, as well as the Therapy Preference Questionnaire (TPQ)<br>•Treatment impact on social daily living and health care resource utilization<br>;Primary end point(s): The primary variable is progression-free survival.