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

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Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III 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Metastatic Nasopharyngeal Carcinoma The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA) Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Administration of Epstein Barr Virus – Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal 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Brief Title

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

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Overall response rate

Secondary Outcome

 Time to disease progression or death, survival time, duration of response, complete response rate.

Condition

Nasopharyngeal Cancer

Intervention

Oxaliplatin

Study Arms / Comparison Groups

 1
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

25

Start Date

April 2007

Completion Date

September 2009

Primary Completion Date

September 2009

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Clinical Trials, ,

Location Countries

Morocco

Location Countries

Morocco

Administrative Informations

NCT ID

NCT00439426

Organization ID

ML20508

Responsible Party

Sponsor

Study Sponsor

Hoffmann-La Roche

Study Sponsor

Clinical Trials, Study Director, Hoffmann-La Roche

Verification Date

November 2016