Docetaxel and Epirubicin in Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae Yong Cho, Yonsei University
ClinicalTrials.gov Identifier:
NCT00375999
First received: September 13, 2006
Last updated: January 14, 2014
Last verified: January 2014

September 13, 2006
January 14, 2014
September 2006
December 2006   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00375999 on ClinicalTrials.gov Archive Site
Not Provided
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Docetaxel and Epirubicin in Advanced Gastric Cancer
A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.

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 Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints:

  1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure.
  2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
Drug: Docetaxel and epirubicin
Other Names:
  • taxotere
  • pharmorubicin
Experimental: docetaxel and epirubicin
salvage docetaxel and epirubicin
Intervention: Drug: Docetaxel and epirubicin
Lim JY, Cho JY, Paik YH, Lee DK, Lee SI, Park HJ, Lee SJ, Lee KS, Yoon DS, Choi SH. Salvage chemotherapy with docetaxel and epirubicin for advanced/metastatic gastric cancer. Oncology. 2007;73(1-2):2-8. doi: 10.1159/000120027. Epub 2008 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
December 2006
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00375999
2004-232
Not Provided
Jae Yong Cho, Yonsei University
Yonsei University
Not Provided
Principal Investigator: Jae Yong Cho Yonsei University
Yonsei University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP