Status:
COMPLETED
Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Gastrointestinal Cancer
Cancer of Unknown Primary Site
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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 att...
Detailed Description
Fluoropyrimidines (FPs) are widely used chemotherapy agents for the management of patients with colorectal, breast, upper gastrointestinal, head and neck cancers. Capecitabine is an oral prodrug of 5-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01845337
Start Date
February 5 2014
End Date
October 8 2020
Last Update
May 12 2023
Active Locations (1)
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1
Edinburgh Cancer Centre
Edinburgh, Scotland, United Kingdom, EH4 2XU