Patients with histological proven adenocarcinoma of the stomach and/or esophageal gastric junction
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Product Code: 9198
Pharmaceutical Form: Concentrate for solution for infusion
Product Name: Eloxatin
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I: 1. Histological proven adenocarcinoma of the stomach and/or esophageal gastric junction (distal 2 cm of oesophagus) 2. Age = 18 years 3. WHO performance status 0-1 4. Life expectancy of more than 3 months 5. Adequate haematological function: ANC = 1.5 x 109/L, platelets = 100 x 109/L 6. Adequate renal and hepatic function: total bilirubin = 1.5 x upper normal limit, ASAT and/or ALAT = 3 x upper normal limit, no upper limit in case of liver metastases 7. Creatinine clearance = 30 ml/min. 8. First treatment day planned within 8 days after randomization 9. Written informed consent prior to randomization Phase II: Same as phase I AND 1. Measurable lesion according to RECIST 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: Phase I and II: 1. Prior chemotherapy > 6 months before inclusion 2. Neuropathy 3. Prior treatment with Taxotere, Oxaliplatin or Xeloda 4. Past or concurrent history of malignant neoplasm except for non-melanoma skin cancer 5. Evidence of brain metastases 6. Concomitant administration of any other experimental drug or within 14 days before inclusion 7. Other serious illness or medical conditions (e.g.: myocardial infarction, infection) 8. Pregnant or lactating women 9. Known allergy towards taxanes, 5-FU or platinum 10. Patients who cannot take oral medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To determine max. tolerable dose (MTD) for the combination regime docetaxel, oxaliplatin and capecitabine (TEX) as first line treatment to patients with primary or recurrent non-resectable cancer of the stomach Phase II: To estimate response rate for treatment with TEX as first line treatment to patients with primary or recurrent non-resectable cancer of the stomach;Secondary Objective: Phase I: To estimate toxicity for the TEX-regime and to determine the dose level for the regime for phase II Phase II: To evaluate time to progression (TTP), overall survival and toxicity ;Primary end point(s): Phase I: to determine maximum tolerable dose (MTD) for the combination regimen of docetaxel, oxaliplatin and capecitabine (TEX) as first line treatment for patients with primary or recurrent non-resectable gastric cancer Phase II: to evaluate response rate for the TEX-regime as first line treatment for patients with primary or recidual non-resectable gastric cancer | — |
Countries
Denmark
Outcome results
None listed