Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

• Status: Terminated
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow response to a cold pressor test, in a patient population who are being treated for adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens, either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heikki Joensuu
• Treatments: Capecitabine; Oxaliplatin; Tegafur

Criteria

Inclusion Criteria:

• Has given written informed consent.

• Is at least 18 years of age.

• Has advanced or metastatic gastrointestinal tract adenocarcinoma.

• No previous cancer chemotherapy for cancer.

• Measurable or evaluable lesions according to RECIST v1.1 criteria.

• Is able to take medications orally.

• Has ECOG performance status 0 or 1.

• Has a life expectancy of at least 3 months.

• Has adequate organ function.

Exclusion Criteria:

• Cancer considered operable without prior chemotherapy.

• Prior chemotherapy to cancer.

• Previous therapy with fluoropyrimidines or anthracyclines for any indication.

• Inability to swallow tablets.

• Known brain metastasis or leptomeningeal metastasis.

• History of myocardial infarction, coronary stenting/graft.

• History of unstable angina, coronary/peripheral artery bypass graft.

• History of cerebrovascular accident or transient ischemic attack.

• History of pulmonary embolism or deep vein thrombosis.

• Symptomatic congestive heart failure.

• Ongoing cardiac dysrhythmias.

• Patients with any cardiac disease that requires regular medication.

• Hypertensive crisis or severe hypertension that is not controlled.

• Is a pregnant or lactating female.

• The cardiac arterial flow tests cannot be done.