METRONOMIC CHEMOTHERAPY WITH URACIL/TEGAFUR (UFT), CYCLOPHOSPHAMIDE (CTX) AND CELECOXIB IN PRETREATED PATIENTS WITH ADVANCED GASTROINTESTINAL MALIGNANCIES: A PILOT CLINICAL STUDY WITH PHARMACOKINETIC AND PHARMACODYNAMIC EVALUATIONS - COMET-GI

• Conditions: PATIENTS WITH ADVANCED GASTROINTESTINAL MALIGNANCIES; MedDRA version: 9.1Level: LLTClassification code 10061174Term: Gastrointestinal neoplasm

• Registration Number: EUCTR2007-000065-38-IT
• Lead Sponsor: AZIENDA USL 6 LIVORNO ZONA LIVORNESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <= 2; - adequate bone marrow reserve (white blood cells >= 3000/mm3 and platelets >= 100000/mm3); - adequate renal function (serum creatinine <= 2 mg/dL) and hepatic function (serum bilirubin <= 1,5 x UNL, AST/ALT <= 5 x UNL); - no history of recent myocardial infarction or unstable cardiac disease; - any prior chemotherapy or radiotherapy interrupted at least 4 weeks before; - no CNS symptomatic metastases; - signed 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

- encephalic metastases - Crohn's diseases, inflammatory intestinal diseases - methabolic diseses or infaction - ischemic myocardial acute - failure cardiac - pregnancy - neoplasm secondary

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified