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A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stomach Neoplasms

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Trial Information

A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.


Inclusion Criteria:



- Male and female outpatients ≥ 18 years,

- ECOG 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
RECIST 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: WBC>4,000/mm3 or ANC>
2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin 1 x UNL (Upper
normal limit), AST/ALT levels <2.5X UNL, alkaline phosphatase < 5 x UNL (except
in case of bone metastasis without any liver disease) - Renal function:
Creatinine <1 x UNL or creatinine clearance ≥ 60ml/min.

Exclusion Criteria:

- 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-ALAT, ASAT > 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jae Yong Cho

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University

Authority:

Korea, Republic of: Yonsei University

Study ID:

2004-232

NCT ID:

NCT00375999

Start Date:

Completion Date:

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms

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