PATIENTS WITH ADVANCED GASTROINTESTINAL MALIGNANCIES MedDRA version: 9.1 Level: LLT Classification code 10061174 Term: Gastrointestinal neoplasm
Conditions
Interventions
Trade Name: ENDOXAN BAXTER*EV 1FL 1G
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Cyclophosphamide
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
T
Sponsors
AZIENDA USL 6 LIVORNO ZONA LIVORNESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed metastatic colorectal, pancreatic, gastric, haepatocellular and biliary tract cancers; - Documented progressive disease (RECIST criteria); - age >= 18 years; - patient not suitable for a standard treatment with chemotherapy, hormonotherapy or targeted agents for metastatic disease or who have already received medical oncological therapies but no further standard treatments available; - measurable disease (RECIST criteria); - performance status ECOG = 3000/mm3 and platelets >= 100000/mm3); - adequate renal function (serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - encephalic metastases - Crohn's diseases, inflammatory intestinal diseases - methabolic diseses or infaction - ischemic myocardial acute - failure cardiac - pregnancy - neoplasm secondary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percentage of patients free of progression at 2 months;Secondary Objective: - Progression free survival ? Response rate ? Overall survival ? Safety profile ? Pharmacodynamic analysis of plasma sVEGFR-2 and TSP-1 ? Pharmacokinetic analysis of 5-FU, uracil and tegafur;Primary end point(s): Percentage of patients free of progression at 2 months | — |
Countries
Italy
Outcome results
None listed