Patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction
Conditions
Interventions
Trade Name: Paclitaxel Albumin
Product Name: nab-Paclitaxel
Pharmaceutical Form: Suspension for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: ml/cm2 millilitre(s
Sponsors
Hellenic Oncology Research Group (H.O.R.G.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction) Age > 18 years old Assessable target lesion(s) as defined by RECIST criteria v1.1 Disease progression after treatment with the DCF regimen ECOG performance status = 1 Hgb = 8g/dL, WBC = 3 x 109/L , neutrophils count = 1.5 x 109/L , platelets =100 x 109/L Creatinine clearance =50 mL/min Total bilirubin = 1.5 X UNL AST, ALT and ALP = 2.5 x UNL Estimated life expectancy more than 3 months Written informed consent 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 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 59
Exclusion criteria
Exclusion criteria: Gastrointestinal bleeding Clinically relevant, symptomatic excessive amounts of ascites resulting in patient’s discomfort CNS metastases Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. Known hypersensitivity reaction to the component of the treatment. Active infection or malnutrition or bowel obstruction. Legal incapacity or limited legal capacity Definite contraindications for the use of corticosteroids History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. Chronic inflammation of the bowel. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent. Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the objective response (CR and PR) rates of nab-Paclitaxel as salvage treatment in patients with metastatic/locally advanced gastric or GEJ cancer previously treated with DCF.;Secondary Objective: To estimate Progression Free Survival (PFS), median Overall Survival (mOS), and evaluate the safety profile of nab-Paclitaxel in pretreated patients with metastatic/locally advanced gastric or GEJ cancer. To determine predictive biomarkers of response or resistance in the primary tumor of enrolled patients.her language that is applicable;Primary end point(s): Documented Objective Response Rate (ORR) will be assessed every two months (3 treatment cycles) according to RECIST vs.1.1 criteria for tumor response (RECIST criteria version 1.1) .;Timepoint(s) of evaluation of this end point: Every 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival (PFS) is defined as the median time interval from the time of enrolment to the date of first documented of disease progression, or patient’ death of any cause. Median Overall Survival (mOS) is considered as the interval from the time of enrolment to the date of patient’ death of any cause. Safety assessment will be based on the incidence of adverse events, SAEs, modifications in laboratory parameters, dose reductions or treatment delays and treatment discontinuations due to toxicity or deterioration of performance status. Adverse events (AEs) will be evaluated according to NCI-Common Toxicity Criteria version 4.0 (National Cancer Institute Common Toxicity Criteria v4.0; Siegel R). AEs will be evaluated every 2 weeks, before the administration of the next treatment cycle. Haematology test with differential neutropheels count will be performed every week during the treatment and every 2 months during the follow-up period. Biochemistry test will be performed every 2 weeks during the treatment and every 2 months during the follow-up period. Vital sign and ECG will be assessed every 2 weeks, before the administration of the next treatment cycle. Exploratory analysis of predictive biomarkers will be performed in the primary tumors of the enrolled patients. Analysis of gene correlated with resistance (TXR1, TSP1) or sensitivity (BRCA1) will be carried with the use of RT-qPCR. ;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Countries
Greece
Contacts
Public ContactIoannis Athanasakis
Hellenic Oncology Research Group (H.O.R.G.)
Outcome results
None listed