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

Phase 2

Completed

• Conditions: Metastatic Advanced Gastric Cancer
• Interventions: Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks

• Registration Number: NCT01624025
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-17
• Study First Posted: 2012-06-20
• Primary Completion: 2015-09
• Study Completion: 2016-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HER2 positive	Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks	Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
HER2 negative	Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks	Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen. (Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)

Primary Outcome Measures

Name	Time	Method
disease control rate according to the RECIST v1.1	at 6~8 weeks later after the first evaluation	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.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of