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Completed

NCT Number: NCT02608073

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

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.

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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

Hong Kong

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Capecitabine

Drug

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 names: Xeloda

Cisplatin

Drug

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 outcomes

  1. Overall response rate

    Time frame: up to 28 days after the last intake of study treatment (up to approximately 5 years)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Nov 18, 2015
Registry last updated
Mar 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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