Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatment cabazitaxel
Phase phase 2
Sponsor Prof. Dr. S.E. Al-Batran
Start date September 2013
End date September 2016
Trial size 65 participants
Trial identifier NCT01956149, CabaGast

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
cabazitaxel
20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.

Primary Outcomes

Measure
Disease Control Rate (DCR)
time frame: up to 17 months

Secondary Outcomes

Measure
Overall survival (OS)
time frame: up to 17 months
Progression-free survival (PFS)
time frame: up to 17 months
Response rate by subgroup (with and without previous treatment with a taxane)
time frame: up to 17 months
Toxicity
time frame: up to 18 weeks
Correlation of circulating tumor cells with PFS and OS
time frame: up to 18 weeks
Correlation of circulating tumor cells with the clinical response
time frame: up to 18 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach
Principal investigator Harald Schmalenberg, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Krankenhaus Nordwest.