Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, second-line treatment, Cabazitaxel, response
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cabazitaxel
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Krankenhaus Nordwest
Frankfurt am Main, Germany
Status: Recruiting
Contact: Salah-Eddin Al-Batran, MD - +496976014420 - albatran@aol.com
Universitätsklinikum Jena
Jena, Germany
Status: Recruiting
Contact: Harald Schmalenberg, MD - +493641933114 - Harald.Schmalenberg@med.uni-jena.de
Start Date
September 2013
Completion Date
July 2016
Sponsors
Krankenhaus Nordwest
Source
Krankenhaus Nordwest
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page