Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Cabazitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabazitaxel<br>Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22 | Drug: Cabazitaxel<br>* 20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | 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) | up to 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | From date of randomization until the date of death from any cause, assessed up to 17 months | up to 17 months | 
| Progression-free survival (PFS) | 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 | up to 17 months | 
| Response rate by subgroup (with and without previous treatment with a taxane) | 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) | up to 17 months | 
| Toxicity | incidence and intensity of adverse events | up to 18 weeks | 
| Correlation of circulating tumor cells with PFS and OS | samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks). | up to 18 weeks | 
| Correlation of circulating tumor cells with the clinical response |  | up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, second-line treatment, Cabazitaxel, response