Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)

Advanced Gastric Cancer Clinical Trial

Official title:

A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743964
• Other study ID #: SMC IRB 2008-04-027
• Secondary ID: 01-9-0804027
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: January 13, 2010
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Aged 75 years or less

• Adenocarcinoma of stomach

• Advanced, metastatic, or recurrent

• No prio chemotherapy for advanced disease

• Adequate performance status

• Adequate major organ functions

Exclusion Criteria:

• Severe comorbid illness or active infections

• Pregnancy or lactating women

• GI obstruction or malabsorption syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Epirubicin
Epirubicin 50 mg/m2 iv on day 1
• Cisplatin, capecitabine
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival		six months	No
Secondary	progression-free survival		six months	No