Capecitabina and gemcitabina are singularly active drugs in the dealt breast cancer and with various profile of toxicity
Conditions
Sponsors
AZIENDA USL 6 LIVORNO ZONA LIVORNESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - diagnosis of metastatic breast cancer - age between 18 and 75 years - performance status WHO 0-2 - measurable disease second criteria RECIST - adapted medullary functionalities leucociti 3,0 109/L and neutrophil 1,5 109/L, platelets 150 109/L, HgB 9 g/dl - hepatic functionality as it follows total bilirubine 1,25 times x the value limit; ALT and ALP 2,5 times x the value limit - creatinine 1,3 mg/dl - previous treatment with antracycline and taxanes in the adjuvant therapy and/or of the metastatic disease or however contraindications to I use of these two drugs 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: - previous chemotherapy with capecitabine, gemcitabine or 5-fluorouracil administrated in continuous infusion - not more than two chemoterapic regimes comprised the adjuvant treatment - presence of sintomatich cerebral metastases - scompensate metabolic diseases or infections in action - not controlled cardiac arrhythmies or ischemica cardiopathy - acute infarct of the myocardium in the last year - oral anticoagulant assumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dose finding study to determine maximum tolerated dose MTD of gemcitabine for combination chemotherapy with capecitabine. Phase II study.;Secondary Objective: nobody;Primary end point(s): Evaluation of OR determinated with Recist Critera | — |
Countries
Italy
Outcome results
None listed