Phase II Trial of PS-341 (Bortezomib, NSC-681239) Followed by the Addition of Gemcitabine at Progression in Recurrent or Metastatic Nasopharyngeal Carcinoma
OBJECTIVES: Primary I. Assess the response probability (confirmed and unconfirmed, complete
and partial responses) and 3-month progression-free survival rate in patients with
metastatic or recurrent nasopharyngeal carcinoma (NPC) who are treated with bortezomib.
Secondary I. Estimate 1-year progression-free survival and assess quantitative toxicities in
this group of patients treated with bortezomib.
II. Evaluate the response probability (confirmed and unconfirmed, complete and partial) in
the subset of patients who progress on bortezomib, with measurable disease at the time of
progression, and go on to receive bortezomib and gemcitabine hydrochloride combination
III. Estimate 1-year overall survival of all patients treated with this regimen.
IV. Estimate 6-month progression-free survival from the start of combination therapy and
assess quantitative toxicities in the subset of patients who progress on bortezomib and
receive combination therapy.
V. Explore, in a preliminary manner, the relationship between changes in Epstein-Barr virus
DNA level, NF-kB DNA-binding activity, and methylation status of E-cadherin promoter with
OUTLINE: This is a multicenter study of bortezomib.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity. Patients achieving a complete
response (CR) receive 2 additional courses of treatment with bortezomib.
Patients who experience disease progression on single-agent bortezomib and did not receive
prior gemcitabine hydrochloride may begin combination therapy within 10-28 days of the last
dose of bortezomib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1
and 8 and bortezomib IV on days 1, 4, 8, 11. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity. Patients achieving a CR receive 2
additional courses beyond the confirmed CR.
After the completion of study treatment, patients are followed periodically for up to 3
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (confirmed and unconfirmed, complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST) in patients treated with bortezomib
Up to 3 years
Southwest Oncology Group
United States: Food and Drug Administration
|Southwest Oncology Group||San Antonio, Texas 78245|