Docetaxel and Epirubicin in Advanced Gastric Cancer

NCT ID: NCT00375999

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2006-12-31

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 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).

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

docetaxel and epirubicin

salvage docetaxel and epirubicin

Group Type: EXPERIMENTAL

Docetaxel and epirubicin

Intervention Type: DRUG

Interventions

Docetaxel and epirubicin

Intervention Type: DRUG

Other Intervention Names

taxotere; pharmorubicin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Jae Yong Cho

Chisf of Medical oncology, Gangnam Severance Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae Yong Cho

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Yongdong Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 18332648 (View on PubMed)

Other Identifiers

2004-232

Identifier Type: -

Identifier Source: org_study_id