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

Fecha de inicio: 1 de junio de 2004

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