Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine (TOFFEE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by University of Edinburgh
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01845337
First received: April 29, 2013
Last updated: May 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Cancer
 Drug: Teysuno
Drug: Capecitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Toxicity OF Fluoropyrimidines: A Comparative Study of the Cardiotoxicity of capEcitabine and tEysuno

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • The primary endpoint of the study will be a difference in the duration of ST deviation pre-treatment and during treatment. [ Time Frame: Pre treatment and between day 5-7 ] [ Designated as safety issue: Yes ]
    This will be recorded using Del Mar Reynolds Lifecard CF/Lifecard 12 recorders, which will record 12 leads over 24 hours and continuously if the storage card is changed daily. Pre-treatment control ECGs will be recorded for 24 hours. Continuous 12-lead monitoring shall be recorded for three days between day 5 and 7 of treatment.
Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capecitabine single agent
Capecitabine 1250 mg/m2 twice daily, days 1-14 every 21 days
 Drug: Capecitabine
Other Name: Xeloda tablets
Active Comparator: Capecitabine /Oxaliplatin
Capecitabine 1000 mg/m2 twice daily, days 1-14 every 21 days (in frail or elderly patients, a CAP dose of 750 mg/m2 BD should be considered). Oxaliplatin will be given as an iv infusion at a dose of 130 mg/m2 over 2-6 hours on day 1.
 Drug: Capecitabine
Other Name: Xeloda tablets
Active Comparator: Teysuno single agent
Teysuno will be administered at a dose of 30 mg/m2 twice daily, for 14 days, with a subsequent 7-day rest period. Patients will be assigned a dose on the basis of body surface area (BSA) and will receive one of the following doses twice daily: 40mg (BSA < 1.5 m2), 45 mg (BSA 1. 5 to < 1.7 m2), 55mg (BSA 1.7 - 1.9 m2),
 Drug: Teysuno
Other Name: Tegafur / Gimeracil / Oteracil
Active Comparator: Teysuno/ Oxaliplatin
Teysuno will be administered orally at a dose of 25mg/m2 twice daily, days 1-14 every 21 days Patients will be assigned a dose on the basis of body surface area (BSA) and will receive one of the following doses twice daily: 35mg (BSA < 1.5 m2), 40mg (BSA 1.5 to < 1.7 m2), 45mg (BSA 1.7 - 1.9 m2), 50mg (BSA >1.9 m2). Oxaliplatin will be given as an iv infusion at a dose of 130 mg/m2 over 2-6 hours on day 1.
 Drug: Teysuno
Other Name: Tegafur / Gimeracil / Oteracil

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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 <3 x upper limit of normal (ULN), alkaline phosphatase <5x ULN, and serum transaminase (either AST or ALT) <5 x ULN
    • Estimated creatinine clearance >50 mL/min (Cockcroft and Gault, adjusted for BSA; Appendix ?) or estimated glomerular filtration rate (eGFR) >50 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845337

Contacts
Contact: Sally Clive, MBChB MD 0131 777 350 sallyclive@nhslothian.scot.nhs.uk
Contact: Natalie J Peel, MBChB 07751577040 nataliepeel@hotmail.com

Locations
United Kingdom
University of Edinburgh Not yet recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XR
Contact: Sally Clive, MBChB    0131 777 350      
Principal Investigator: Sally Clive, MBChB         
Sub-Investigator: Natalie Peel, MBChB         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Sally Clive, MBChB University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01845337     History of Changes
Other Study ID Numbers: 2012-005282-12
Study First Received: April 29, 2013
Last Updated: May 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
 Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015