Gastric Cancer
Conditions
Keywords
gastric cancer, second-line treatment, Cabazitaxel, response
Brief summary
Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.
Detailed description
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.
Interventions
DRUGCabazitaxel
20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.
Sponsors
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to 17 months | Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 17 months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 17 months |
| Response rate by subgroup (with and without previous treatment with a taxane) | up to 17 months | Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months) |
| Overall survival (OS) | up to 17 months | From date of randomization until the date of death from any cause, assessed up to 17 months |
| Correlation of circulating tumor cells with PFS and OS | up to 18 weeks | samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks). |
| Correlation of circulating tumor cells with the clinical response | up to 18 weeks | — |
| Toxicity | up to 18 weeks | incidence and intensity of adverse events |
Countries
Germany
Outcome results
None listed