NCT02608073

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_2

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

5 years

First QC Date

November 16, 2015

Last Update Submit

March 1, 2016

Conditions

Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

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

Secondary Outcomes (7)

  • Overall survival

    Up to approximately 18 months

  • Time to disease progression

    Up to approximately 18 months

  • Duration of response

    Up to approximately 18 months

  • Complete response rate

    Up to approximately 18 months

  • Incidence of adverse events

    Up to approximately 7 months

  • +2 more secondary outcomes

Study Arms (1)

Capecitabine + Cisplatin

EXPERIMENTAL

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: CapecitabineDrug: Cisplatin

Interventions

CapecitabineDRUG

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).

Also known as: Xeloda
Capecitabine + Cisplatin
CisplatinDRUG

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).

Capecitabine + Cisplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Yogyakarta, 55284, Indonesia

Location

Unknown Facility

Kuala Lumpur, 50603, Malaysia

Location

Unknown Facility

Kueishan, 333, Taiwan

Location

Unknown Facility

Taipei, 00112, Taiwan

Location

Unknown Facility

Taipei, 106, Taiwan

Location

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

CapecitabineCisplatin

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

November 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

MY(1)HK(2)ID(1)TW(3)TH(2)