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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Metastatic Advanced Gastric Cancer

Treatments: Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks

Study type: Interventional

Funder types: Other

Identifiers

NCT01624025

4-2012-0222

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

HER2 positive

Experimental group

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)

Treatment:

Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks

HER2 negative

Active Comparator group

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)

Treatment:

Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks