Conditions: Nasopharyngeal Cancer
Keywords: gemcitabine carboplatin cisplatin erlotinib tarceva nasopharyngeal
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression. A cycle of erlotinib will be 28 days. Patients who progress on GC will be offered erlotinib as well,in order to evaluate its activity as a single-agent in the second-line setting.

Patients previously treated with GC have reported a progression-free survival (PFS) of 9 months. We would anticipate an extension of PFS to 12 months in patients treated with GC followed by maintenance erlotinib. Furthermore, we hypothesize that patients who achieved benefit from GC therapy would have further response when treated with maintenance erlotinib, such that this strategy may increase the likelihood of attaining long-term survival.

Detailed description:

Arms:
arm 1: Eligible patients are treated with cisplatin/carboplatin and gemcitabine (GC) for 6 cycles of therapy followed by maintenance erlotinib. Those patients achieving SD or PR with chemotherapy will be started on maintenance erlotinib until disease progression. Those patients achieving CR with chemotherapy will be started on erlotinib for 6 cycles of treatment and those achieving CR on erlotinib will be treated with a maximum of 6 further cycles of erlotinib. Those patients with disease progression while on chemotherapy will be offered erlotinib 2 weeks following the last dose of chemotherapy until further disease progression.

Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin/Cisplatin intervention 3: erlotinib
Intervention descriptions: intervention 1: 1000mg/m\^2 intravenous (IV) day 1 and day 8 intervention 2: Area under curve (AUC)=5 (Carboplatin) or 70mg/m\^2 (Cisplatin) intravenous (IV) day 1 intervention 3: 150mg daily (post GC therapy)

Protocol document: