Docetaxel and Epirubicin in Advanced Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375999
• Other study ID #: 2004-232
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2006
• Last updated: January 14, 2014
• Start date: September 2006
• Est. completion date: December 2006

Study information

• Verified date: January 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea, Republic of: Yonsei University
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Docetaxel and epirubicin

Locations

Country	Name	City	State
Korea, Republic of	Yongdong Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		One year	No