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

Nasopharyngeal Cancer Clinical Trial

Official title:

An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439426
• Other study ID #: ML20508
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2007
• Last updated: November 1, 2016
• Start date: April 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Morocco: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-75 years of age;

• history of nasopharyngeal cancer and distant metastases;

• no previous chemotherapy in past 6 months;

• recovery from previous radiotherapy;

• ability to swallow and retain oral medication.

Exclusion Criteria:

• previous cytotoxic chemotherapy;

• radiotherapy within 4 weeks of treatment start;

• history of another malignancy within the last 5 years;

• clinically significant cardiac disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Oxaliplatin
130mg/m2 iv on day 1 of each 3 week cycle
• capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Event driven	No
Secondary	Time to disease progression or death, survival time, duration of response, complete response rate.		Event driven	No
Secondary	AEs, laboratory parameters.		Throughout study	No