patients with advanced colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastatic
Conditions
Interventions
Trade Name: XELODA 120CPR RIV 500MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2000-
Trad
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 3.1.2 Histologically confirmed adenocarcinoma 33.1.4 Presence of at least one measurable lesion 3.1.5 Age 8805; 18 years and 75 years 3.1.6 Karnofsky performance status of 70 at study entry 3.1.7 Life expectancy of 3 months 3.1.8 Laboratory data Neutrophils 8805; 1.5 x 109/L, platelets 8805; 100 x 109/L, hemoglobin 8805; 9 g/dl ALAT and ASAT 8804; 2.5 x ULN 5 x ULN if liver metastases are present Total Bilirubin 8804; 1.5 x ULN Serum creatinine 8804; 1.5 x ULN 3.1.9 Effective contraception in female patients at risk of conception/absence of pregnancy or breastfeeding 3.1.10 Signed written informed consent. 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: 3.2.1 Brain metastasis 3.2.2 Previous chemotherapy for locally advanced or metastatic colorectal adjuvant therapy without oxaliplatin is allowed if recurrence is documented 6 months after the end of adjuvant treatment 3.2.5 Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months 3.2.6 Acute or subacute intestinal occlusion or history of the inflammatory bowel disease 3.2.7 Patients with peripheral neuropathy NCI CTC 1 3.2.8 Known grade 3 or 4 allergic reaction to any of the components of the treatment 3.2.9 Known drug abuse/alcohol 3.2.10 Legal incapacity or limited legal capacity 3.2.11 Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent 3.2.12 Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 2.1.1 To investigate the efficacy of Oxaliplatin in combination Xeloda in patients with locally advanced or metastatic colorectal cancer, not previously treated with chemotherapy.;Secondary Objective: Safety of combination 2.2.2.b toxicity of combination 2.2.2.c Time-to-disease progression 2.2.2.d Median response duration 2.2.2.e Overall survival time;Primary end point(s): To investigate the efficacy of Oxaliplatin in combination Xeloda | — |
Countries
Italy
Outcome results
None listed