Bortezomib Followed by the Addition of Doxorubicin at Disease Progression in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma (Cancer) of the Head and Neck

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well bortezomib followed by doxorubicin at the time of disease progression works in treating patients with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (cancer) of the head and neck. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with doxorubicin may kill more tumor cells

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: Southwest Oncology Group
• Treatments: Bortezomib; Doxorubicin; Liposomal doxorubicin

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