Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach

Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.

65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 Cabazitaxel for a maximum of 6 cycles. Main objective of the study is the Disease Control Rate (DCR) with Cabazitaxel.

Inclusion Criteria:

1. Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
2. Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.
3. Male and female patients aged > 18 years
4. ECOG ≤ 1
5. neutrophils ≥ 1500/µl
6. Haemoglobin ≥ 9 g/dl
7. Platelets ≥ 100,000/µl
8. AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
9. Total bilirubin ≤1.0 x ULN
10. Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
11. Written patient informed consent

Exclusion Criteria:

1. A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
2. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
3. Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
4. Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
5. Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment
6. Peripheral polyneuropathy > NCI grade II
7. Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)
8. Chronic inflammatory bowel disease
9. Participation in another study
10. Pregnancy or lactation