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A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT02608073
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancer Drug: Capecitabine Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
Study Start Date : November 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine + Cisplatin
Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles.
Drug: Capecitabine
Participants will receive oral capecitabine, 1000 mg/m^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
Other Name: Xeloda

Drug: Cisplatin
Participants will receive cisplatin, 100 mg/m^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 28 days after the last intake of study treatment (up to approximately 5 years) ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to approximately 18 months ]
  2. Time to disease progression [ Time Frame: Up to approximately 18 months ]
  3. Duration of response [ Time Frame: Up to approximately 18 months ]
  4. Complete response rate [ Time Frame: Up to approximately 18 months ]
  5. Incidence of adverse events [ Time Frame: Up to approximately 7 months ]
  6. Quality of life according to Visual Analog Scale (VAS) score [ Time Frame: Up to approximately 6 months ]
  7. Treatment convenience/satisfaction according to VAS score [ Time Frame: Up to approximately 6 months ]


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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
Criteria

Inclusion Criteria:

  • Adults 18 to 75 years of age
  • Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
  • Ability to swallow and retain oral medication

Exclusion Criteria:

  • Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
  • Clinically significant cardiac disease
  • History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
  • Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study

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 ClinicalTrials.gov identifier (NCT number): NCT02608073


Locations
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Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Indonesia
Jogjakarta, Indonesia, 55284
Malaysia
Kuala Lumpur, Malaysia, 50603
Taiwan
Kueishan, Taiwan, 333
Taipei, Taiwan, 00112
Taipei, Taiwan, 106
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02608073     History of Changes
Other Study ID Numbers: ML18123
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016

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