patients with metastatic gastric carcinoma MedDRA version: 14.1 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TAXOTERE*INFUS FL 160MG/8ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg/m2 milligram(s)/square
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age =18, - Histologically or cytologically confirmed adenocarcinoma of the stomach or lower third of the oesophagus, - HER2/NEU status as negative (IHC 1-2+; FISH negative). - Clinical stage: T4 N-/+ M0 or TxNxM1; local relapse not amenable to curative surgery. - The stage classification is clinical and will be defined by the most appropriate method (Physical exam, EGDS, EUS, CT, MRI). - ECOG Performance Status of 0 or 1. - Royal Marsden Hospital prognostic index, Group 1(See appendix). - No previous chemotherapy for advanced or locally relpsed disease. - Previous adjuvant chemotherapy completed at least 6 months before registration. - Measurable/evaluable disease, according to the (NCI-CTCAE v.3) criteria. - Baseline laboratory values: absolute neutrophil count (ANC) =2000/mm3, hemoglobin >10.0 g/dL, platelet count =100,000/mm3??creatinine 60 ml/min, transaminases 3 months. -Recovery from acute effects of surgery. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: - HER2+ positivity (immunohistochemistry 3+ or fluorescence in situ hybridization–amplified). -Previous chemotherapy for metastatic or relapsed disease. -New York Heart Association Class 3 or 4 heart disease. -Clinically significant heart disease, including but not limited to: myocardial infarction within the last 6 months, congestive heart failure, unstable angina, clinically significant pericardial effusion or serious arrhythmia. -Peripheral neuropathy grade = 2 according to the NCI-CTCAE v.3. -Any serious active infection (uncontrolled or requiring treatment). -Any history or evidence of CNS disease, e.g. brain metastases. -Any known hypersensitivity to study drug components. -Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. -Pregnant or lactating women. -Fertile patients (male and female) unwilling to use effective means of contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (RR) according to the RECIST Criteria;Secondary Objective: - Progression free survival (PFS), - Overall Survival (OS), - Disease Control Rate (DCR), - Safety profile, - Quality of life (EORTC QLQ-C30 and QLQ-STO22).;Primary end point(s): Response rate (RR) according to the RECIST Criteria;Timepoint(s) of evaluation of this end point: Taking into account the relatively rarity of the disease and the strict selection criteria (Her2/neu negative and Royal Marsden Prognostic score 0-1), it is anticipated that a total of three eligible patients per month will be randomized, considering also a 10% of not evaluable patients, a 27 month period of accrual and further 18 month of follow up will be estimated to reach the primary and secondary objective | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression free survival (PFS), - Overall Survival (OS), - Disease Control Rate (DCR), - Safety profile, - Quality of life (EORTC QLQ-C30 and QLQ-STO22).;Timepoint(s) of evaluation of this end point: Taking into account the relatively rarity of the disease and the strict selection criteria (Her2/neu negative and Royal Marsden Prognostic score 0-1), it is anticipated that a total of three eligible patients per month will be randomized, considering also a 10% of not evaluable patients, a 27 month period of accrual and further 18 month of follow up will be estimated to reach the primary and secondary objective | — |
Countries
Italy
Contacts
Public ContactGruppo Ricerca Clinico-terapeutica
Centro di Riferimento Oncologico IRCCS CRO Aviano
Outcome results
None listed