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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00743964

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Gastric Cancer	Drug: Epirubicin Drug: Cisplatin, capecitabine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ECX Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.	Drug: Epirubicin Epirubicin 50 mg/m2 iv on day 1 Drug: Cisplatin, capecitabine Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
Active Comparator: CX Cisplatin and capecitabine combination chemotherapy will be administered.	Drug: Cisplatin, capecitabine Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.

Arm

Intervention/Treatment

Experimental: ECX

Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.

Drug: Epirubicin

Epirubicin 50 mg/m2 iv on day 1

Drug: Cisplatin, capecitabine

Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.

Active Comparator: CX

Cisplatin and capecitabine combination chemotherapy will be administered.

Drug: Cisplatin, capecitabine

Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.

Outcome Measures

Primary Outcome Measures

Failure-free survival [six months]

Secondary Outcome Measures

progression-free survival [six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135 710

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00743964

Other Study ID Numbers:

SMC IRB 2008-04-027
01-9-0804027

First Posted:

Aug 29, 2008

Last Update Posted:

Jan 15, 2010

Last Verified:

Jan 1, 2010

Additional relevant MeSH terms:

Stomach Neoplasms

Capecitabine

Epirubicin

Study Results

No Results Posted as of Jan 15, 2010