Trial Information

Summary: A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Metastatic Nasopharyngeal Cancer

Status: No longer recruiting

Protocol Number: ML18123

Sponsor: Roche Hong Kong Limited

Company Division: Pharmaceutical

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

Brief Summary: This study will evaluate the efficacy, safety, tolerability and effect on quality of life of Xeloda in combination with cisplatin in patients with metastatic nasopharyngeal cancer. Patients will receive up to 8 cycles of Xeloda treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is 3-12 months, 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:

Interventional

Condition: Nasopharyngeal Cancer

Intervention Type: Drug

Intervention Name: capecitabine[Xeloda]

Primary Outcome: 1. Efficacy: Overall response rate .

Key Secondary Outcomes: 1. Efficacy: Time to disease progression, survival time, response duration, and complete response rate. Safety: Adverse events and laboratory tests Quality of life: FACT-H&N questionnaire, Chemotherapy Convenience and Satisfaction questionnaire (CCSQ)

Inclusion Criteria:

  • adult patients 18-75 years of age;
  • histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer;
  • >=1 measurable lesion that has not been irradiated;
  • able to swallow and retain oral medication.

Exclusion Criteria:

  • previous cytotoxic chemotherapy (except when given as adjuvant, concurrent, or neoadjuvant treatment and completed >=6 months before enrollment);
  • clinically significant cardiac disease;
  • history of another malignancy within last 5 years, except cured basal cell cancer of skin and cured cancer in situ of cervix;
  • radiotherapy within 4 weeks of treatment start or prior radiotherapy to the indicator lesion(s) being measured in the study.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2004

Trial Registration Date: 10/21/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Taipei, Taiwan, 100
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: June 30, 2008 at 4:59:26 PM


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