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
bortezomib
+ doxorubicin hydrochloride
+ laboratory biomarker analysis
Adenocarcinoma+13
+ Carcinoma
+ Carcinoma, Adenoid Cystic
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.37 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically confirmed adenoid cystic carcinoma of the head and neck * Locally advanced, recurrent, or metastatic disease that is considered incurable by known therapies * Unidimensionally measurable disease * Must not have stable disease for at least 9 months before study entry * No known brain metastases * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * AST and ALT no greater than 2.5 times upper limit of normal * Bilirubin normal * Creatinine normal * Creatinine clearance at least 60 mL/min * LVEF at least lower limit of normal by MUGA * No history of congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active or ongoing infection * No prior allergy to compounds of similar chemical or biological composition to bortezomib * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No pre-existing neuropathy \> grade 1 * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * See Chemotherapy * No prior anthracyclines, including any of the following: * Doxorubicin * Epirubicin * Daunorubicin * Idarubicin * No prior mitoxantrone * No prior high-dose chemotherapy for bone marrow transplantation * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * At least 3 weeks since prior radiotherapy * At least 3 weeks since prior surgery * More than 4 weeks since prior investigational drugs * No other concurrent anticancer therapy or agents
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location