Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems including heart attacks. An alternative drug, called teysuno is used extensively in other countries instead of capecitabine and appears to have less of a bad effect on the heart whilst still killing cancer cells. This study will investigate the effect of these two drugs on the heart and blood vessels and will be the first of its kind in humans.

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

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: NHS Lothian
• Treatments: Capecitabine; Oxaliplatin; Tegafur

Criteria

Inclusion Criteria:

• Male or female patients at least 18 years or over with no upper age limit.

• Confirmed advanced or metastatic oesophageal, gastric, gastro-oesophageal, small bowel, colorectal, hepatobiliary or pancreatic cancer or cancer of unknown primary.

• Suitable for treatment with fluoropyrimidine, either alone or in combination with oxaliplatin.

• WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo planned chemotherapy and cardiac investigations.

• Baseline laboratory tests (within 1 week prior to starting treatment):

• Neutrophils >1.5 x109 /L and platelet count > 100 x109 /L

• Serum bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase <5x ULN, and serum transaminase (either AST or ALT) <3 x ULN

• Estimated glomerular filtration rate (eGFR) >30 mL/min (Patients with eGFR 30-50 mL/min will be included but should be treated at a reduced dose (see master prescription chart).

• For women of childbearing potential; negative pregnancy test and adequate contraceptive precautions.

• Effective contraception for male patients if the risk of conception exists.

• Written informed consent for participation in the trial.

Exclusion Criteria:

• Patients who are unfit for the chemotherapy regimens in this protocol, such as:

• Known intolerance to CAP or other FPs

• Severe uncontrolled concurrent medical illness likely to interfere with protocol treatments

• Poorly controlled angina or MI in previous 6 months

• Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication

• Partial or complete bowel obstruction

• Pre-existing neuropathy > grade 1 if combination therapy proposed

• Patients on therapeutic anticoagulation (warfarin or LMWH).

• Patients unable to lie flat.

• Patients unable to withstand the visits and cardiovascular investigations proposed within the study.