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

Roche

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: 5-Fluorouracil; Drug: Capecitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02563054

ML17032

Details and patient eligibility

About

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.

Enrollment: 316 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 2 patient groups

5-Fluorouracil + Cisplatin

Active Comparator group

Description:

Participants will receive 5-FU in combination with cisplatin upto disease progression.

Treatment:

Drug: 5-Fluorouracil

Drug: Cisplatin

Capecitabine + Cisplatin

Experimental group

Description:

Participants will receive capecitabine in combination with cisplatin upto disease progression.

Treatment:

Drug: Capecitabine

Drug: Cisplatin