Open-label randomized, parallel group, phase III, multicenter trial comparing two different sequences of therapy (irinotecan/cetuximab followed by fluorouracil/leucovorin with oxaliplatin (FOLFOX-4) vs. FOLFOX-4 followed by irinotecan/cetuximab) in metastatic colorectal patients treated with fluorouracil/leucovorin with irinotecan (FOLFIRI)/bevacizumab as first line chemotherapy - COMETS [COlorectal Metastatic Two Sequences]
- Conditions
- Patients with histologically confirmed metastatic colorectal cancer progressed after a first line treatment containing FOLFIRI and BEV.MedDRA version: 9.1Level: LLTClassification code 10061045Term: Colon neoplasm
- Registration Number
- EUCTR2007-006254-26-IT
- Lead Sponsor
- GISCAD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Age >18 < 75 years of age
Diagnosis of histologically proven adenocarcinoma of the colon or rectum, stage IV
ECOG performance status 0-1 at study entry
Neutrophils ≥ 1.5 x 109 /uL, platelets ≥ 100 x 109/uL, and hemoglobin ≥ 9 g/dL
Bilirubin level either normal or < 1.5 x ULN
ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
Serum creatinine < 1.5 x ULN
Effective contraception for both male and female patients if the risk of conception exists
Life expectancy of ≥ 3 months
Signed written informed consents
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
History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake
Known grade 3 or 4 allergic reaction to any of the components of the treatment
Known drug abuse/ alcohol abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: overall survival;Secondary Objective: Progression free survival<br>Quality of life, evaluated by means a VAS scale<br>Health resource utilisation and economic evaluation<br>Toxicity and incidence of adverse events;Primary end point(s): ACTIVITY<br>TOXICITY<br>QUALITY of LIFE
- Secondary Outcome Measures
Name Time Method