A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine
Overview
- Phase
- Phase 2
- Intervention
- Trifluridine/Tipiracil
- Conditions
- Colorectal Adenocarcinoma
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Enrollment
- 1
- Locations
- 11
- Primary Endpoint
- Rate of cardiovascular events at 3 months.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to assess the incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain due to fluoropyrimidines in the adjuvant or metastatic setting .
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 14-day screening period to determine eligibility for study entry. Patient who meet the eligibility requirement will be included in the study and will be treated by trifluridine/tipiracil +/- oxaliplatin.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •For metastatic colo-rectal-cancer, MSI and/or dMMR tumor
- •For metastatic oeso-gastric and gastric adenocarcinoma, HER+++ or HER++ FISH positive tumor
- •Left ventricular dysfunction with a left ventricular ejection fraction (LVEF) \< 35% with or without an automatic implantable defibrillator,
- •Non-revascularized multivessel coronary artery disease,
- •ACS with ST elevation, and/ or troponin rise
- •QT/QTc interval \> 470 ms (for women) and \> 450 ms (for men) NB: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: //www.crediblemeds.org.")
- •Documented coronary vasospasm during 5-FU treatment leading to myocardial infarction,
- •Pregnancy and breastfeeding,
- •Treatment with any other investigational medicinal product within 28 days (4 weeks) before start of the study treatment,
- •Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose-galactose malabsorption,
Arms & Interventions
trifluridine/tipiracil +/- oxaliplatin
Trifluridine/tipiracil 35 mg/m² orally twice a day from day 1 to day 5 plus oxaliplatin 85 mg/m² intravenous at day 1 every 14 days. If oxaliplatin is stopped for neurotoxicity, allergic reaction or other reason, or it is not indicated, patients will continue trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.
Intervention: Trifluridine/Tipiracil
trifluridine/tipiracil +/- oxaliplatin
Trifluridine/tipiracil 35 mg/m² orally twice a day from day 1 to day 5 plus oxaliplatin 85 mg/m² intravenous at day 1 every 14 days. If oxaliplatin is stopped for neurotoxicity, allergic reaction or other reason, or it is not indicated, patients will continue trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.
Intervention: Oxaliplatin
Outcomes
Primary Outcomes
Rate of cardiovascular events at 3 months.
Time Frame: At 3 months
Assessment of the rate of cardiovascular events in patients treated by trifluridine/tipiracil +/- oxaliplatin over a 3-month period.
Secondary Outcomes
- Number of patients with treatment-related adverse events by CTCAE 5.0(Assessed up to 48 months)
- The 3-month drop-out rate of limiting toxicity(At 3 months)
- Number of patients with disease control rate (DCR)(Assessed up to 48 months)