Studio randomizzato, in aperto di fase II per valutare efficacia e sicurezza di FOLFOX-4 piu' cetuximab rispetto a UFOX piu' cetuximab come terapia di prima linea in soggetti affetti da carcinoma del colon retto metastatico - Future

Conditions: patients with metastatic colorectal cancer
MedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic

Registration Number: EUCTR2006-000685-36-IT

Lead Sponsor: Merck KGaA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Signed written informed consent
Inpatient or outpatient >=18 years of age
Diagnosis of histologically confirmed
adenocarcinoma of the colon or rectum
First occurrence of metastatic disease (not curatively
resectable)
Presence of at least one lesion measurable uni
dimensionally by CT scan or MRI. (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 109/L, with
neutrophils >=1.5 x 109/L, platelets >=100 x 109/L, and
hemoglobin >=9 g/dL
AST and ALT <=2.5 x ULN (<=5 x ULN if liver
metastasis are present)
Normal serum creatinine (in case of elevated
creatinine, labelled EDTA clearance >65 mL/min is
acceptable)
Effective contraception for both male and female
subjects if the risk of conception exists
Tumor biopsy or archived 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

Brain metastasis and/or leptomeningeal disease
(known or suspected)
Previous chemotherapy for colorectal cancer 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,
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 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
Primary end point(s): Efficacy: Progression or its absence, response and<br>duration of response of the tumor(s) to therapy based on<br>imaging and classified according to the ‘Response<br>Criteria In Solid Tumors' (RECIST).;Main Objective: Comparison of progression-free survival in subjects<br>receiving cetuximab plus either UFOX or FOLFOX-4 as<br>initial treatment for metastatic CRC;Secondary Objective: Response rate (CR and PR) in each treatment group<br>- Overall survival (OS) in each treatment group<br>- Safety<br>- Quality of Life (QOL) (FACT-C, EQ-5D and<br>Therapy Preference Questionnaire [TPQ])<br>- Treatment impact on social daily living and health<br>care resource utilization

Secondary Outcome Measures