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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00743964
First received: August 27, 2008
Last updated: January 13, 2010
Last verified: January 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Se Hoon Park, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00743964     History of Changes
Other Study ID Numbers: SMC IRB 2008-04-027, 01-9-0804027
Study First Received: August 27, 2008
Last Updated: January 13, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Epirubicin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014