Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
SWOG Cancer Research Network
Conditions:
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Salivary Gland Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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. Second...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00077428
Start Date
June 1 2004
Last Update
January 24 2013
Active Locations (1)
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1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215