A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT00603915
Phase
PHASE2
Status
Completed

Conditions

  • Nasopharyngeal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    1000mg/m\^2 intravenous (IV) day 1 and day 8
  • Carboplatin/Cisplatin — DRUG
    Area under curve (AUC)=5 (Carboplatin) or 70mg/m\^2 (Cisplatin) intravenous (IV) day 1
  • erlotinib — DRUG
    150mg daily (post GC therapy)

Study Details

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.

Key Dates

First listed
Jan 29, 2008
Start date
Jun 30, 2006
Status verified
Feb 2019
Primary completion
Dec 31, 2010
Completion
Apr 30, 2011

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GC Plus Erlotinib
    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.

Primary Outcome Measure

Progression Free Survival. [ Time Frame: From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died. ]

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