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Completed

NCT Number: NCT02563054

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-fluorouracil

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Time to disease progression

    Time frame: Up to approximately 7.3 years

Secondary outcomes

  1. Objective tumor response rate

    Time frame: Up to approximately 7.3 years

  2. Overall survival

    Time frame: Up to approximately 7.3 years

  3. Duration of response

    Time frame: Up to approximately 7.3 years

  4. Time to response

    Time frame: Up to approximately 7.3 years

  5. Incidence of adverse events

    Time frame: Up to approximately 7.3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Sep 29, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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