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

August 16, 2016 updated by: Yonsei University
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6~8 weeks later after the first evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 17, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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