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OpenTrials
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NCT Number: NCT00439426

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

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.

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Key information

Conditions

Nasopharyngeal Cancer Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Agadir, Morocco

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

130mg/m2 iv on day 1 of each 3 week cycle

capecitabine [Xeloda]

Drug

1000mg/m2 po bid on days 1-14 of each 3 week cycle

Primary outcomes

  1. Overall response rate

    Time frame: Event driven

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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