Trial comparing the effects of two chemotherapy drugs on the heart

• Conditions: All gastrointestinal and hepatobiliary cancers including colorectal cancer, cancer of unknown primary, pancreatic cancer, stomach cancer and oesophageal cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005282-12-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-03
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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, cancer of unknown primary, hepatobiliary or pancreatic cancer.
•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 creatinine clearance (Cockcroft and Gault, adjusted for BSA>50 mL/min or estimated glomerular filtration rate (eGFR) or measured GFR (EDTA clearance) >30 mL/min. [Patients with Cr Cl 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Patients who are unfit for the chemotherapy regimens in this protocol, such as:
-Severe uncontrolled concurrent medical illness (including poorly controlled angina or very recent MI, i.e. in previous 3 months) likely to interfere with protocol treatments
-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 DELETED
•Patients on therapeutic anticoagulation (warfarin or LMWH).
•Patients unable to lie flat. DELETED
•Patients unable to withstand the visits and cardiovascular investigations proposed within the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified