Trial Information

Summary: A Study of Xeloda (Capecitabine) in Patients With Advanced or Metastatic Gastric Cancer

Status: No longer recruiting

Protocol Number: ML17032

Sponsor: Roche Products Pty Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of first-line chemotherapy with Xeloda plus cisplatin versus 5-fluorouracil plus cisplatin on time to disease progression in patients with advanced or metastatic gastric cancer

Brief Summary: This study will evaluate the efficacy and safety of oral Xeloda versus 5-fluorouracil, in combination with intravenous cisplatin, in patients with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Gastric Cancer

Intervention Type: Drug

Intervention Name: capecitabine[Xeloda]

Primary Outcome: 1. Efficacy: Non-inferiority, time to progression of disease, or death.

Key Secondary Outcomes: 1. Efficacy: Overall response rate, survival time, duration of response, and time to response Safety: Adverse events and laboratory tests

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • advanced and/or metastatic gastric cancer;
  • >=1 measurable lesion.

Exclusion Criteria:

  • uncontrolled infection;
  • evidence of central nervous system metastases;
  • history of another malignancy within the last 5 years except cured basal cell cancer of skin and cured in-situ cancer of uterine cervix;
  • radiation therapy or major surgery within 4 weeks of treatment start;
  • previous chemotherapy.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2003

Trial Registration Date: 08/31/2005

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Sorocaba, Brazil, 18030-210
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:16:14 PM


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