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

NCT00743964 | Completed Phase 2

• 2 other identifiers: SMC IRB 2008-04-02701-9-0804027
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  six months

Secondary Outcomes (1)

• progression-free survival

  six months

Study Arms (2)

ECX

EXPERIMENTAL

Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.

Drug: Epirubicin; Drug: Cisplatin, capecitabine

CX

ACTIVE COMPARATOR

Cisplatin and capecitabine combination chemotherapy will be administered.

Drug: Cisplatin, capecitabine

Interventions

Epirubicin DRUG

Epirubicin 50 mg/m2 iv on day 1

ECX

Cisplatin, capecitabine DRUG

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

CX; ECX

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe comorbid illness or active infections
• Pregnancy or lactating women
• GI obstruction or malabsorption syndrome

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135 710, South Korea

Location

Related Publications (1)

• Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010 Mar;46(5):885-91. doi: 10.1016/j.ejca.2009.12.015. Epub 2010 Jan 7.

  PMID: 20060288 DERIVED

MeSH Terms

Interventions

Epirubicin; Cisplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 15, 2010

Record last verified: 2010-01

Locations

KR (1)