Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Head and Neck Adenoid Cystic Carcinoma
Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11,
and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be
added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of
14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days
1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease
progression or intolerable toxicity emerges (see section 5 for detailed treatment plan and
dose modifications).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the objective response rate and stable disease rates, progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma.
5 years
Yes
Athanassios E Argiris, MD
Principal Investigator
Principal Investigator
United States: Institutional Review Board
06-124
NCT00581360
November 2007
November 2012
Name | Location |
---|---|
UPMC Cancer Center - Uniontown | Uniontown, Pennsylvania 15401 |
UPMC Cancer Center - Teramana Cancer Center - Steubenville | Steubenville, Ohio 43952 |
UPMC Cancer Center - Beaver | Beaver, Pennsylvania 15009 |
UPMC Cancer Center - Clairton | Clairton, Pennsylvania 15025 |
UPMC Cancer Center - Oakbrook Commons - Greensburg | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center - Indiana | Indiana, Pennsylvania 15701 |
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown | Johnstown, Pennsylvania 15901 |
UPMC Cancer Center - McKeesport | McKeesport, Pennsylvania 15132 |
UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group | Moon Township, Pennsylvania 15108 |
UPMC Cancer Center - Passavant | Pittsburgh, Pennsylvania 15237 |
UPMC Cancer Center - Mercy | Pittsburgh, Pennsylvania 15219 |
UPMC Cancer Center - Washington | Washington, Pennsylvania 15301 |
UPMC Cancer Center -Mosside Blvd. | Monroeville, Pennsylvania 15146 |
UPMC Cancer Center -Haymaker Rd. | Monroeville, Pennsylvania 15146 |
UPMC Cancer Center -Mt. Pleasant | Mt. Pleasant, Pennsylvania 15666 |
UPMC Cancer Center -New Castle | New Castle, Pennsylvania 16105 |
UPMC Cancer Center -Drake | Pittsburgh, Pennsylvania 15241 |
UPMC Cancer Center -Delafield Rd. | Pittsburgh, Pennsylvania 15215 |
UPMC Cancer Center -Wexford | Wexford, Pennsylvania 15090 |
University of Pittsburgh Cancer Institute-Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |