Esophagus, cardiac or ventricular cancer MedDRA version: 14.0 Level: LLT Classification code 10025899 Term: Malignant neoplasm of esophagus System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Oxaliplatin
Product Name: Oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825943
Concentration unit: mg/m2 milligram(
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients with histologically proven ECV-adenocarcinoma, non-resectable or metastatic disease 2. HER2-positive tumor tissue (IHC 3 + or FISH positive) 3. LVEF > 50 % (MUGA scan or eccocardiography) 4. Age = 18 years 5. No prior chemotherapy 6. WHO performance status 0-1 7. Lifeexpectancy of at least 3 months 8. Neutrophils = 1.5 x 109/L and platelets = 100 x 109/L 9. Bilirubin = 1.5 x UNL (Upper Normal Limit) and ASAT and/or ALAT = 3 x UNL. In case of liver metastases no UNL for ASAT and ALAT 10. Creatinine clearance = 50 ml/min. Calculated with the Cockroft-Gault formular 11. No neuropathy 12. Planned treatment start within 8 days after inclusion 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: 1. Patients who cannot complete treatment or evaluation 2. Any condition or treatment which after the opinion of the investigator may expose the patients to a risc or influence the purpose of the study 3. Known hypersensitivity towards any of the study drugs 4. Other malignant disease within the last 5 days, except for non-melanoma skin cancer 5. Other serious disease (e.g. cardiac disease, AMI within 1 year or infection) 6. Pregnant women or nursing women 7. Physical or mental conditions which may prevent absorption of oral treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine maximum tolerable dose (MTD) for the combination regime TEX (docetaxel, oxaliplatin and capecitabine) + trastuzumab and to evaluate the toxicity ;Secondary Objective: - Progression free survival - Survival - Response rate;Primary end point(s): The primary end point is to determine maximum tolerable dose (MTD) of the combination of TEX + trastuzumab. Further the toxicity will be evaluated. | — |
Countries
Denmark
Outcome results
None listed