Trial Information

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

Status: 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

Anticipated Start Date: March, 2007

Trial Registration Date: 02/16/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:58:08 PM