TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without bevacizumab in patients with platinum-refractory esophago-gastric adenocarcinoma
Conditions
Sponsors
Lene Bæksgaard Jensen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Age = 18 years. o Histologically verified esophago-gastric adenocarcinoma (EGA). o Non-resectable and/or metastatic disease. o Measurable or non-measurable disease. o Performance status (WHO) of 0-1 and a life expectancy of at least 3 months. o Previous therapy with fluoropyrimidines (5FU, capecitabine or S-1) and platinum (cisplatin, oxaliplatin, or carboplatin). o Adequate haematological function defined as neutrophils ? 1.5 x 109/l and platelets = 100 x 109/l. o Adequate organ function (bilirubin = 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min. o Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomisation. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) during the study and for 6 months after the discontinuation of study medication. o Has provided written informed consent prior to performance of any study procedure. o Written informed consent must be obtained according to the local Ethics Committee requirements. 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 53 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
Exclusion criteria: o Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and except any other cancer in complete remission for at least 2 years. o Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives (e.g. infection; drainage of ascites or pleural effusion within 4 weeks; intestinal obstruction; uncontrolled diabetes; AMI within 12 months; severe/unstable angina; known HIV or hepatitis B or C; major surgery within 4 weeks; uncontrolled hypertension). o Known allergy or intolerance to any of the drugs used (Lonsurf, bevacizumab). Known CNS metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 6 months after end of trial (last visit last patient);Main Objective: The purpose of this study is to evaluate the efficacy and tolerability of Lonsurf with or without bevacizumab in Caucasian patients with platinum-refractory esophago-gastric adenocarcinoma. Primary objective is Progression Free Survival (PFS);Secondary Objective: Secondary objectives include Overall survival (OS), Response rate (RR), Disease Control Rate, Time to Deterioration (TtD) in Performance Status, Toxicity and Correlation between bio-markers and outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives include Overall survival (OS), Response rate (RR), Disease Control Rate (DCR), Time to deterioration (TtD) in Performance Status (PS), Toxicity and Correlation between bio-markers and outcome;Timepoint(s) of evaluation of this end point: 6 months after end of trial (last visit last patient) | — |
Countries
Denmark
Contacts
Public ContactDept of Oncology,Rigshospitalet
Lene Bæksgaard Jensen
Outcome results
None listed