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
Adénocarcinome+13
+ Carcinome
+ Carcinome adénoïde kystique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2004
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.37 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site