A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563054
• Other study ID #: ML17032
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2015
• Last updated: November 1, 2016
• Start date: April 2003
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea, republic of: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults 18 to 75 years of age

• Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion Criteria:

• Uncontrolled infection

• Evidence of central nervous system (CNS) metastases

• History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix

• Radiation therapy or major surgery within 4 weeks of study drug

• Previous chemotherapy

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 5-Fluorouracil
Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.
• Capecitabine
Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.
• Cisplatin
Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Belize,  Brazil,  China,  Colombia,  Guatemala,  Hong Kong,  Korea, Republic of,  Malaysia,  Mexico,  Panama,  Peru,  Russian Federation,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression		Up to approximately 7.3 years	No
Secondary	Objective tumor response rate		Up to approximately 7.3 years	No
Secondary	Overall survival		Up to approximately 7.3 years	No
Secondary	Duration of response		Up to approximately 7.3 years	No
Secondary	Time to response		Up to approximately 7.3 years	No
Secondary	Incidence of adverse events		Up to approximately 7.3 years	No