Trial | NCT01956149  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    65
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.
Study Started
Sep 30
2013
Primary Completion
Dec 31
2017
Study Completion
Apr 04
2018
Last Update
Apr 18
2018

Drug Cabazitaxel

20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.

Cabazitaxel Experimental

Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted