Patients with Advanced Gastric Cancer MedDRA version: 9.1 Level: LLT Classification code 10063916 Term: Metastatic gastric cancer
Conditions
Interventions
Trade Name: TAXOTERE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · age ≥ 18 years · written informed consent· histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the oesophagus· disease stage: advanced, recurrent or metastatic· uni-dimensionally measurable disease, as assessed by CT and MRI scan in accordance with the RECIST guidelines · prior adjuvant or neoadjuvant treatment for locoregional resectable disease completed at least 3 weeks before study initiation, and could not have included oxaliplatin or docetaxel· radiotherapy ? no prior RT other than adjuvant where relapse is outside the radiotherapy fields · ECOG Performance status 0, 1 or 2· life expectancy > 12 weeks· adequate liver (bilirubin 1500/µl; platelets > 100000/µl, haemoglobin > 9g/dl) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: .prior systemic therapy for advanced or metastatic disease· history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix· any medical or psychiatric condition that impairs ability to give informed consent· uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmia?s· clinically significant abnormal ECG or cardiac history (e.g.: patients with myocardial infarction within the last 6 months)· any other serious uncontrolled medical conditions· any pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine the DLT and recommended dose of docetaxel to be given in combination with oxaliplatin and capecitabine;Secondary Objective: to evaluate the safety and tolerability of the drugs in combination;Primary end point(s): to determine the DLT and recommended dose of docetaxel to be given in combination with oxaliplatin and capecitabine | — |
Countries
Italy
Outcome results
None listed