Docetaxel and Epirubicin in Advanced Gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00375999
• Date of registration: 13/09/2006
• Prospective Registration: No
• Primary sponsor: Yonsei University
• Public title: Docetaxel and Epirubicin in Advanced Gastric Cancer
• Scientific title: A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
• Date of first enrolment: September 2006
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00375999
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jae Yong Cho
• Affiliation: Yonsei University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 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, 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stomach Neoplasms

Intervention(s)

Drug: Docetaxel and epirubicin

Primary Outcome(s)

Overall Survival [Time Frame: One year]

Secondary ID(s)

2004-232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00375999