Recurrent Nasopharyngeal Cancer Clinical Trial
Official title:
Phase II Trial of PS-341 (Bortezomib, NSC-681239) Followed by the Addition of Gemcitabine at Progression in Recurrent or Metastatic Nasopharyngeal Carcinoma
This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells
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
therapy.
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
clinical outcomes.
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
years.
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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00091182 -
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
|
Phase 2 | |
| Completed |
NCT01806675 -
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
|
Phase 1/Phase 2 | |
| Completed |
NCT00101270 -
Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas
|
Phase 1 |