Back to resultsA Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
Primary Purpose
Metastatic Advanced Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Advanced Gastric Cancer focused on measuring AGC, second-line, docetaxel, epirubicin
Eligibility Criteria
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.
Sites / Locations
- Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HER2 positive
HER2 negative
Arm Description
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01624025
Brief Title
A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Advanced Gastric Cancer
Keywords
AGC, second-line, docetaxel, epirubicin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HER2 positive
Arm Type
Experimental
Arm Description
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
Arm Title
HER2 negative
Arm Type
Active Comparator
Arm Description
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
Intervention Type
Other
Intervention Name(s)
Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
Intervention Description
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
Primary Outcome Measure Information:
Title
disease control rate according to the RECIST v1.1
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.
Time Frame
at 6~8 weeks later after the first evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin
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