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Phase 2
20 Years
Not Enrolling
Metastatic Advanced Gastric Cancer

Thank you

Trial Information

Inclusion Criteria:

1. Histologically confirmed metastatic, or recurrent AGC

2. 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.

3. Documented HER2 expression status.

4. Radiologically proven progression of disease.

5. Age > 20 years

6. ECOG PS 0 - 2

7. Life expectancy more than 3 months

8. 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)

9. Written informed consent

Exclusion Criteria:

1. 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.

2. 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

3. Active CNS metastasis not controllable with radiation or steroid

4. Concurrent administration of systemic chemotherapy or radiotherapy. Palliative
radiotherapy for pain control more than 2 weeks ago is acceptable.

5. Pregnant or lactating women.

6. Peripheral neuropathy G3~4.

7. Metachronous malignancy other than adequately treated CIN of uterine cervix, basal
cell or squamous cell carcinoma of the skin.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease control rate according to the RECIST v1.1

Outcome Description:

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.

Outcome Time Frame:

at 6~8 weeks later after the first evaluation

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

July 2012

Completion Date:

June 2015

Related Keywords:

  • Metastatic Advanced Gastric Cancer
  • AGC, second-line, docetaxel, epirubicin
  • Stomach Neoplasms