Recurrent Salivary Gland Cancer Clinical Trial
Official title:
Phase II Trial of PS-341 (NSC 681239) Followed by the Addition of Doxorubicin at Progression in Advanced Adenoid Cystic Carcinoma of the Head and Neck
This phase II trial is studying how well bortezomib followed by doxorubicin at the time of disease progression works in treating patients with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (cancer) of the head and neck. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with doxorubicin may kill more tumor cells
OBJECTIVES: Primary I. Determine the objective tumor response in patients with locally
advanced, recurrent, or metastatic adenoid cystic carcinoma of the head and neck treated
with bortezomib.
Secondary I. Determine the time to progression in patients treated with this drug. II.
Determine the overall survival of patients treated with this drug. III. Determine the toxic
effects of this drug in these patients. IV. Determine the objective tumor response, time to
progression, and overall survival of patients who progress on single-agent bortezomib and
are then treated with doxorubicin and bortezomib.
V. Determine the toxic effects of this regimen in these patients. VI. Determine the profile
and concentration of inflammatory and angiogenic cytokines in serum of patients before and
in response to this regimen.
VII. Correlate the expression of biomarkers which may be affected by the
ubiquitin-proteasome degradation pathway (NF-kB, p53, p27, cyclin D1, cyclin E, vascular
endothelial growth factor [VEGF], MVD, V-CAM, and N-CAM) on tumor tissue with the clinical
activity of bortezomib in these patients.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity. Patients with
disease progression continue to receive bortezomib as above and doxorubicin IV over 2-5
minutes on days 1 and 8. Treatment repeats every 21 days for up to 14 courses in the absence
of further disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 8 years.
PROJECTED ACCRUAL: A total of 23-37 patients will be accrued for this study within 2.3
years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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