METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA MedDRA version: 20.0 Level: PT Classification code 10053548 Term: Gastrointestinal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ONIVYDE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IRINOTECAN SUCROSOFATE
Current Sponsor code: Nal-IRI
Other descriptive name: IRINOTECAN SUCROSOFATE
Concentration un
Sponsors
fédération francophone de cancérologie digestive
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven metastatic oesophageal squamous cell carcinoma • Patient in failure with 1st-line treatment with oxaliplatin or cisplatin. Patients presenting with resectable disease treated with surgery or neoadjuvant or adjuvant chemotherapy with oxaliplatin or cisplatin (with or without radiotherapy) can be included if a recurrence has occurred less than 6 months after the end of treatment • Age = 18 years • Unresectable disease, measurable or not, according to RECIST 1.1 criteria • WHO performance status = 2 • Neutrophils = 1500/mm3 (without use of haematopoietic growth factors), platelets = 100 000/mm3, haemoglobin = 9 g/dl (blood transfusions are authorised for patients with a haemoglobin less than 9 g/dl) • Total bilirubin = 2 x ULN (biliary drainage is authorised in case of a biliary obstruction); albumin = 25 g/L; AST = 2.5 x ULN, and ALT = 2.5 x ULN (= 5 x ULN in case of hepatic metastases) • Creatinine clearance = 50 ml/min according to MDRD formula • A normal ECG or ECG with no clinically significant findings • Patient able to understand and to sign the informed consent form (or who has a legal guardian able to do so for him/him) • Women of childbearing potential must have a negative pregnancy blood or urine test within 7 days prior to inclusion • Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 4 months following administration of the last dose of the study medicinal product • Patient who is a beneficiary of the Social security system • Patient for whom regular follow-up is possible. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 53 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
Exclusion criteria: • Known brain or bone metastases • Clinically significant gastrointestinal disorders, including hepatic, haemorrhagic, inflammatory, obstructive disorders or diarrhoea > grade 1 • non controlled History of chronic inflammatory bowel disease • Gilbert's syndrome • History of progressive cancer or in remission of less than 3 years duration (patients who present with a cancer in situ or basal cell or squamous cell skin cancer during the last 3 years are eligible). • Severe arterial thromboembolic events (myocardial infarction, unstable angina, stroke) less than 3 months before inclusion • NYHA class III or IV congestive heart failure, ventricular arrhythmia or uncontrolled blood pressure • Significant neuropathy = grade 2 according to NCI CTCAE criteria (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.0. • Known hypersensitivity or allergy to a component of the medicinal products used in the study. • Known DPD deficiency • An investigational treatment administered during the 4 weeks prior to day one of chemotherapy scheduled in this study. • Use of potent CYP3A4 enzyme inhibitors or inducers, or existence of other contraindications to irinotecan. • Patient under guardianship and/or deprived of his/her freedom • Pregnant women or breastfeeding mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the survival of patients at 9 months;Secondary Objective: • Progression-free survival (PFS) (clinical and/or radiological) • Overall survival (OS) • Best response rate during treatment according to RECIST 1.1 criteria (according to the investigator and the centralised review committee) • Toxicity (NCI CTC 4.0) • Quality of life (QLQ-C30 and OES18 questionnaires of the EORTC);Primary end point(s): The primary objective is to evaluate the percentage of patients alive 9 months after randomisation. ;Timepoint(s) of evaluation of this end point: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary evaluation end points are: • Progression-free survival (PFS): PFS is defined as the time interval between date of randomisation and date of first progression (clinical and/or radiological: RECIST 1.1 criteria) determined by the investigator, or date of death (whatever the cause). Patients alive without progression will be censured at date of last news. • Overall survival (OS): OS is defined as the time interval between date of randomisation and date of death (whatever the cause). Patients alive will be censured at date of last news. • Best response rate: • The best response rate is defined as the best response rate obtained during treatment. This end point will be evaluated solely in patients measurable with RECIST 1.1 criteria. This rate will be described as an objective response rate: complete response or partial response (CR, PR) according to the investigator (RECIST 1.1 criteria) and also by centralised review. • Toxicity It will be evaluated and graded in conformity with NCI-CTC v4.0 criteria. • Quality of life (QLQ-C30 questionnaires of EORTC + OES18 of EORTC) ;Timepoint(s) of evaluation of this end point: 9 months | — |
Countries
France
Contacts
Public Contactclinical project manager
fédération francophone de cancérologie digestive
Outcome results
None listed