A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin

Study Overview
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Brief Summary
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A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study

Conditions
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Metastatic Advanced Gastric Cancer

Intervention / Treatment
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* Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic, or recurrent AGC Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial. Documented HER2 expression status. Radiologically proven progression of disease. Age > 20 years ECOG PS 0 - 2 Life expectancy more than 3 months Adequate organ function for treatment including liver, kidney and bone marrow (absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 100,000/ul, AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement, Total serum bilirubin ≤ 2.0 mg/dL) Written informed consent Exclusion Criteria: Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed. Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF < 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements Active CNS metastasis not controllable with radiation or steroid Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable. Pregnant or lactating women. Peripheral neuropathy G3 4. Metachronous malignancy other than adequately treated CIN of uterine cervix, basal cell or squamous cell carcinoma of the skin.

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2 positive<br>Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks) | Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks<br>* Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.<br>|
| Active Comparator: HER2 negative<br>Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen. (Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks) | Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks<br>* Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate according to the RECIST v1.1 | The primary outcome of the current study is the disease control according to the HER2 status. That is, the % of the patients who maintains at least stable disease by RECIST v1.1 at the time of the second tumor evaluation which will be taken at 6 8 weeks later after the first evaluation. The comparison will be done by Pearsons's chi-square test. | at 6 8 weeks later after the first evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AGC, second-line, docetaxel, epirubicin