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

This study is not yet open for participant recruitment.
Verified June 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01624025
First received: June 12, 2012
Last updated: June 17, 2012
Last verified: June 2012
History of Changes
  Purpose

A comparative study of 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.

(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)
No Intervention: 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.

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624025

Contacts
Contact: Sun Young Rha, MD 82-2-2228-8054

Locations
Korea, Republic of
Yonsei University College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sun Young rha, MD            
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01624025     History of Changes
Other Study ID Numbers: 4-2012-0222
Study First Received: June 12, 2012
Last Updated: June 17, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Epirubicin
Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013