Effect of two cancer drugs (S-1 and capecitabine) on the blood circulation of the heart.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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 < upper limit of normal (ULN) for the institution.
10.Has adequate organ function as defined by the following criteria:
a.Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) =2 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) =6 x ULN.
b.Total serum bilirubin of =1.5 x ULN.
c.Absolute neutrophil count of =1,500/mm3 (i.e., =1.5 x 109/L by International Units [IU])
d.Platelet count =100,000/mm3 (IU: =100 x 109/L) (excluding measurements obtained within 7 days after transfusion).
e.Hemoglobin value of =11.0 g/dL.
f.Creatinine < 1.5 x ULN. I creatinine clearance is measured, this should be =60 mL/min based on calculated creatinine clearance (Cockcroft-Gault13 formula, see Appendix D) or 24-hour urine collection.
g.Is willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures

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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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