Trial Information

Summary: A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.

Status: No longer recruiting

Protocol Number: ML20508

Sponsor: Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: An open label study of first line chemotherapy with Xeloda in combination with cisplatin on treatment response in patients with metastatic nasopharyngeal cancer

Brief Summary: This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 42.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Nasopharyngeal Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

Primary Outcome: 1. Overall response rate Time frame: Event driven

Key Secondary Outcomes: 1. Time to disease progression or death, survival time, duration of response, complete response rate. Time frame: Event driven 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 02/16/2007

Date Last Updated: 07/15/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 21, 2008 at 3:18:52 PM