Status:
COMPLETED
Docetaxel and Epirubicin in Advanced Gastric Cancer
Lead Sponsor:
Yonsei University
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary O...
Eligibility Criteria
Inclusion
- Male and female outpatients ≥ 18 years,
- Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
- Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
- Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
- Adequate major organ function : - Hematopoietic function: white blood cell \>4,000/mm3 or absolute neutrophil count \> 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin \< 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels \<2.5 X upper normal limit, alkaline phosphatase \< 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine \<1 x upper normal limit or creatinine clearance ≥ 60ml/min.
Exclusion
- Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count\<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase
- , alanine aminotransferase \> 2.5 X upper normal limit or \> 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase \> 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or \> 10 X upper normal limit in the case of bone disease.
- Prior therapy with Taxotere or Epirubicin is excluded.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00375999
Start Date
September 1 2006
End Date
December 1 2006
Last Update
March 3 2014
Active Locations (1)
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1
Yongdong Severance Hospital
Seoul, South Korea