A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
Conditions
Metastatic Advanced Gastric Cancer
Conditions: Keywords
AGC, second-line, docetaxel, epirubicin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
Type: Other
Overall Status
Recruiting
Summary
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: 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.
Location
Yonsei University College of Medicine
Seoul, Korea, Republic of
Status: Recruiting
Contact: Sun Young Rha, MD
Start Date
July 2012
Completion Date
May 2015
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page