Clinical trial NCT01956149: Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer
Official title: Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
second-line treatment
Cabazitaxel
response
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 17 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 17 months
measure: Progression-free survival (PFS)
timeFrame: up to 17 months
measure: Response rate by subgroup (with and without previous treatment with a taxane)
timeFrame: up to 17 months
measure: Toxicity
timeFrame: up to 18 weeks
measure: Correlation of circulating tumor cells with PFS and OS
timeFrame: up to 18 weeks
measure: Correlation of circulating tumor cells with the clinical response
timeFrame: up to 18 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Krankenhaus Dresden Friedrichstadt
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest
city: Jena
country: Germany
facility: Universitätsklinikum Jena
Study officials:
affiliation: Krankenhaus Dresden Friedrichstadt
name: Harald Schmalenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: