Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer
- Registration Number
- NCT01956149
- Lead Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
- 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.
- Male and female patients aged > 18 years
- ECOG ≤ 1
- neutrophils ≥ 1500/µl
- Haemoglobin ≥ 9 g/dl
- Platelets ≥ 100,000/µl
- AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
- Total bilirubin ≤1.0 x ULN
- Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
- Written patient informed consent
- A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
- Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
- Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
- Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
- 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
- Peripheral polyneuropathy > NCI grade II
- Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)
- Chronic inflammatory bowel disease
- Participation in another study
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cabazitaxel Cabazitaxel Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall survival (OS) up to 17 months From date of randomization until the date of death from any cause, assessed up to 17 months
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)
Toxicity up to 18 weeks incidence and intensity of adverse events
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
Trial Locations
- Locations (3)
Krankenhaus Dresden Friedrichstadt
🇩🇪Dresden, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany