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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624025
First Posted: June 20, 2012
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study

Condition Intervention Phase
Metastatic Advanced Gastric Cancer Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • disease control rate according to the RECIST v1.1 [ Time Frame: 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.


Enrollment: 22
Study Start Date: June 2012
Study Completion Date: February 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HER2 positive
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
Active Comparator: HER2 negative

Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.

(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)

Other: Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624025


Locations
Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01624025     History of Changes
Other Study ID Numbers: 4-2012-0222
First Submitted: June 12, 2012
First Posted: June 20, 2012
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by Yonsei University:
AGC, second-line, docetaxel, epirubicin

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors