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

This study is currently recruiting participants.

Verified by Samsung Medical Center, November 2008

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00743964

Purpose

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	Intervention	Phase
Advanced Gastric Cancer	Drug: Epirubicin Drug: Cisplatin, capecitabine	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Capecitabine Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Failure-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ECX: Experimental Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.	Drug: Epirubicin Epirubicin 50 mg/m2 iv on day 1 Drug: Cisplatin, capecitabine
CX: Active Comparator Cisplatin and capecitabine combination chemotherapy will be administered.	Drug: Cisplatin, capecitabine

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743964

Contacts

Contact: Se Hoon Park, MD

82 2 3410 3459

sh1767.park@samsung.com

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135 710
Contact: Se Hoon Park, MD 82 2 3410 3459 sh1767.park@samsung.com

Sponsors and Collaborators

Samsung Medical Center

More Information

Responsible Party:	Samsung Medical Center ( Se Hoon Park, MD )
Study ID Numbers:	SMC IRB 2008-04-027, 01-9-0804027
Study First Received:	August 27, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00743964
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Epirubicin

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009