Metastatic gastrointestinal tract adenocarcinoma
Conditions
Interventions
Trade Name: Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil.
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TEGAFUR
CAS Number: 17902-23-7
Concentra
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Has given written informed consent. 2.Is >18 years of age. 3.Has advanced or metastatic gastrointestinal tract adenocarcinoma. 4.No previous cancer chemotherapy for cancer. 5.Measurable or evaluable lesions according to RECIST v1.1 criteria. 6.Is able to take medications orally. 7.Has ECOG performance status 0 or 1 on Cycle 1, Day 1 (see Appendix A). 8.Has a life expectancy of at least 3 months. 9.Serum troponin T or I and creatine phosphokinase (CPK)-MB values =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Has had treatment with any of the following within the specified time frame prior to study drug administration: a.Cancer considered operable without prior chemotherapy. b.Prior chemotherapy to cancer. c.Previous therapy with fluoropyrimidines or anthracyclines for any indication. d.Inability to swallow tablets. e.Patients with known DPD deficiency. f.Any investigational agent received either concurrently or within the last4 weeks. g.Current enrollment in another interventional clinical study. 2.Has a serious illness or medical condition(s) including, but not limited to, the following: a.Known brain metastasis or leptomeningeal metastasis. b.Patient with a history of myocardial infarction within the last 6 months, or with a history of coronary surgery or stenting, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or deep vein thrombosis within the last 12 months. c.Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV (see Appendix E). d.Ongoing cardiac dysrhythmias (=Grade 2), atrial fibrillation (any grade), or prolongation of QTc interval (>450 msec for males; >470 msec for females). e.Patients with any cardiac disease that requires regular medication (medication for vascular diseases such as hypertension is allowed). f.Hypertensive crisis or severe hypertension that is not controlled. g.Known acute systemic infection. h.Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator. i.=Grade 1 peripheral neuropathy. j.Recent hemoptysis, coagulopathy and other bleeding disorders considered by the Investigator to be clinically significant. k.Known nephrotic syndrome (proteinuria >2 g/24 hours). l.Known clinically significant interstitial lung disease or pulmonary fibrosis. m.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. n.Organ allografts with immunosuppressive therapy required. o.Major surgery within 3 weeks prior to study treatment start, or lack of complete recovery from the effects of surgery. p.Clinically significant malabsorption syndrome q.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study. 3.Is receiving concomitant treatment with short-acting nitroglycerins, or one or more of the following drugs that may interact with S-1or capecitabine: a.Sorivudine, brivudine, uracil, eniluracil, cimetidine, folinate/folinic acid, and dipyridamole (may enhance S-1or capecitabine activity). b.Nitroimidazoles, including metronidazole and misonidazole (may enhance S-1 activity) c.Clozapine (may increase risk and severity of hematologic toxicity) d.Allopurinol (may diminish S-1 activity). e.Phenytoin (S-1 may enhance phenytoin activity). f.Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity). 4.Is a pregnant or lactating female. 5.Female patients of childbearing potential must have negative pregnancy test before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The frequency of subclinical coronary artery dysfunction, as assessed with the CFR, as compared with the baseline CFR;Secondary Objective: •The CFR between the chemotherapy groups. •The coronary flow response to the CPT as compared to the baseline values and between the chemotherapy groups. •The presence of left ventricle regional wall motion abnormalities or global systolic dysfunction •Cardiac arrhythmias in Holter registration between the 2 groups and as compared to the baseline. •Plasma sensitive troponin concentration between the 2 groups and as compared to the baseline. •Frequency and severity of cardiac symptoms and chest pain during treatment. •Adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) between the 2 treatment groups. •Response rate of cancer to chemotherapy between the 2 treatment groups (RECIST v. 1.1). •Patient preference of chemotherapy (assessed at the completion of chemotherapy when = 3 cycles were given) ;Primary end point(s): The frequency of subclinical coronary artery dysfunction, as assessed with the CFR, as compared with the baseline CFR;Timepoint(s) of evaluation of this end point: Each chemotherapy cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The CFR between the chemotherapy groups. •The coronary flow response to the CPT as compared to the baseline values and between the chemotherapy groups. •The presence of left ventricle regional wall motion abnormalities or global systolic dysfunction •Cardiac arrhythmias in Holter registration between the 2 groups and as compared to the baseline. •Plasma sensitive troponin concentration between the 2 groups and as compared to the baseline. •Frequency and severity of cardiac symptoms and chest pain during treatment. •Adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) between the 2 treatment groups. •Response rate of cancer to chemotherapy between the 2 treatment groups (RECIST v. 1.1). •Patient preference of chemotherapy (assessed at the completion of chemotherapy when = 3 cycles were given) ;Timepoint(s) of evaluation of this end point: Each chemotherapy cycle | — |
Countries
Denmark, Finland
Contacts
Public ContactDepartment of Oncology
Helsinki University Central Hospital
Outcome results
None listed