Nasopharyngeal Cancer
Conditions
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.
Interventions
DRUGCapecitabine
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).
DRUGCisplatin
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).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | up to 28 days after the last intake of study treatment (up to approximately 5 years) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall survival | Up to approximately 18 months |
| Quality of life according to Visual Analog Scale (VAS) score | Up to approximately 6 months |
| Treatment convenience/satisfaction according to VAS score | Up to approximately 6 months |
| Incidence of adverse events | Up to approximately 7 months |
Countries
Hong Kong, Indonesia, Malaysia, Taiwan, Thailand
Outcome results
None listed