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

Roche

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Cancer

Treatments: Drug: Capecitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02608073

ML18123

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Capecitabine + Cisplatin

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Capecitabine