This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous diagnostic procedures and baseline blood specimens for future correlative studies.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
UPMC Cancer Center - Teramana Cancer Center - Steubenville
Steubenville, Ohio, United States
Objective Response Rate (ORR)
ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s
Time frame: Up to 5 years
Stable Disease Rate
Using RECIST v1.0 criteria, stable disease rate is the number participants experiencing stable disease (SD) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD).
Time frame: Up to 5 years
Number of Months of Progression-free Survival (PFS)
Number of months that participants experienced stable disease (the disease does not progress per RECIST v1.0 criteria - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)
Time frame: Up to 5 years
Number of Months of Survival
Number of months that the participant was alive.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UPMC Cancer Center - Beaver
Beaver, Pennsylvania, United States
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg
Greensburg, Pennsylvania, United States
UPMC Cancer Center - Oakbrook Commons - Greensburg
Greensburg, Pennsylvania, United States
UPMC Cancer Center - Indiana
Indiana, Pennsylvania, United States
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown
Johnstown, Pennsylvania, United States
UPMC Cancer Center - McKeesport
McKeesport, Pennsylvania, United States
UPMC Cancer Center -Haymaker Rd.
Monroeville, Pennsylvania, United States
UPMC Cancer Center -Mosside Blvd.
Monroeville, Pennsylvania, United States
...and 11 more locations
Median Duration of Stable Disease Response
Median number of months of Stable Disease Response Per RECIST v1.0 (Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)
Time frame: Up to 36 months