Patients with metastatic colon-rectal cancer MedDRA version: 6.1 Level: PT Classification code 10052358
Conditions
Sponsors
G.O.N.O. Gruppo Oncologico del Nord Ovest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Istologic diagnosis of adenocarcinoma of the colon or the rectum - measurable metastatic Disease second criteria RECIST - not resecabile metastatic Disease -Age 18 years and 75 years - ECOG performance status 2 for patients of age 70 years - ECOG performance status for patients of 0 ages comprised between 71 and 75 years - Attended of advanced life to 3 months - Adapted renal functionality creatininemia 1,25 x VN - hepatic functionality bilirubinemia 1,5 mg/dl, fosfata alkaline, SGOT and SGPT 2,5 x VN in case of hepatic metastases fosfata alkaline, SGOT and SGPT 5 x VN - Adapted medullary functionality emoglobina 10 g/dl, neutrophil 2,0 x 109/L, piastrine 150 x 109/L - adjuvant Chemotherapy with fluoropirimidine or inhibitors of the timidilato sintetasi raltitrexed finished gives beyond 6 months - executed X-ray or surgery gives beyond 4 weeks - informed Consent written 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
Exclusion criteria: - Diagnosis of other malignant neoplasma in last the 10 years except the carcinoma in situ of the cervix uterine and the basalioma or spinalioma cutaneous adequately deals to you - Pregnancy or breast-feeding in course - Previous chemotherapy for metastatic disease - Previous chemotherapy with LOHP or Cpt-11 - adiuvante Chemotherapy with fluoropirimidine finished from less than 6 months - X-ray or surgery executed from less than 4 weeks - Morbo di Crohn, colite ulcerosa or other inflammatory disease of the intestine - Colectomia total or ileostomia - Occlusion or internal subocclusione - scompensate metabolic Diseases or infections in action - not controlled cardiac Arrhythmies or ischemic cardiopathy - Infarct acute of the myocardium in last the 2 years - Impossibility to execute adapted follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity and the optimal profile of toxicity, doses and the antitumor activity in terms of RO of a treatment of biweekly combination that previews the association of Capecitabine oxaliplatin Irinotecan. Evaluation the antitumoral activity of the treatement;Primary end point(s): Until the attainment of the tolerated maximum dose;Secondary Objective: To evaluate 1 time to the progression, 2 overall survival, 3 percentage of radical resections post-chemotherapy of the toxicity metastases and 4 characteristic pharmacokinetics of irinotecan, oxaliplatin and capecitabine in order to identify the patients to risk of serious toxicities because of enzymatic deficits us or of alterations of the characteristic pharmacokinetics and to study the possible interactions between these drugs and their relationship with the tollerability to the treatment. | — |
Countries
Italy
Outcome results
None listed