Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
China
Indonesia
Malaysia
Taiwan
Thailand
