Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine (TOFFEE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by University of Edinburgh.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Edinburgh
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
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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:
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 (Adult, Senior) |
| 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
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
| 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:
|
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Capecitabine |
Tegafur Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 30, 2016