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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439426
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancer Drug: Oxaliplatin Drug: capecitabine [Xeloda] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Oxaliplatin
130mg/m2 iv on day 1 of each 3 week cycle

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

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Event driven ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439426

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Agadir, Morocco, 80000
Casablanca, Morocco, 20502
Marrakech, Morocco, 40000
Rabat, Morocco, 10000
Rabat, Morocco, 6213
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT00439426     History of Changes
Other Study ID Numbers: ML20508
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents