Effects of S-1 and Capecitabine on Coronary Artery Blood Flow
Conditions
Esophagus Cancer - Stomach Cancer - Small Bowel Cancer - Colon Cancer - Rectum Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
fluoropyrimidine, S-1, Teysuno, oxaliplatin, coronary artery flow, coronary artery dysfunction, gastrointestinal tract cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 Type: Drug
Name: Capecitabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
Helsinki University Central Hospital
Helsinki, Finland
Status: Recruiting
Contact: Heikki Joensuu, MD - 947173200 - heikki.joensuu@hus.fi
Start Date
January 2015
Completion Date
August 2019
Sponsors
Heikki Joensuu
Source
Helsinki University Central Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page