Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck

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Brief Title

Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck

Official Title

Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Head and Neck Adenoid Cystic Carcinoma

Brief Summary

      This is a Phase II trial non-randomized study to evaluate the objective response rate and
      stable disease rate (primary endpoints), progression-free survival, overall survival and
      toxicities with the combination of doxorubicin and bortezomib in patients with incurable head
      and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous
      diagnostic procedures and baseline blood specimens for future correlative studies.
    

Detailed Description

      Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and
      doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at
      the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles,
      if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15,
      every 28 days, will be administered alone. Treatment will continue unless disease progression
      or intolerable toxicity emerges (see section 5 for detailed treatment plan and dose
      modifications).
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR)

Secondary Outcome

 Number of Months of Progression-free Survival (PFS)

Condition

Adenoid Cystic Carcinoma

Intervention

doxorubicin and bortezomib

Study Arms / Comparison Groups

 Bortezomib + Doxorubicin
Description:  Patients with incurable adenoid cystic carcinoma of the head and neck who receive doxorubicin and bortezomib

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

November 2007

Completion Date

June 2011

Primary Completion Date

June 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have locally advanced, recurrent, or metastatic adenoid cystic carcinoma
             of the head and neck which is considered incurable by known therapies, as judged by
             the investigator.

          -  Patients should have cytologically or histologically confirmed adenoid cystic
             carcinoma of the head and neck.

          -  Patients must have unidimensionally measurable disease (RECIST criteria). If the only
             site of measurable disease is a previously irradiated area, the patient must have
             documented progression of disease in this area.

          -  All available prior computed tomography (CT) or magnetic resonance imaging (MRI) scans
             should be reviewed and noted, and measurements showing progression of disease should
             be documented whenever possible. However, documentation of disease progression is not
             mandatory for enrollment.

          -  Patients must have multigated acquisition scan (MUGA) scan showing left ventricular
             ejection function (LVEF) at or above the institutional lower limits of normal.

          -  Patients must have ECOG performance status 0-2.

          -  Patients should have recovered from prior surgery or radiation therapy. A minimum time
             period of 3 weeks should elapse between the completion of extensive radiation therapy
             for recurrent/metastatic disease and enrollment in the study.

          -  Patients must have normal organ and marrow function (as defined below) measured within
             one week prior to registration:

          -  Absolute neutrophil count >1,500/mm3.

          -  Platelets greater than or equal to 100,000/mm3.

          -  Total bilirubin within normal institutional limits.

          -  Transaminases (AST and ALT) <3 X ULN.

          -  Creatinine within normal institutional limits or creatinine clearance (CrCl) greater
             than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above
             institutional normal. CrCl will be calculated using the Cockcroft-Gault formula:

          -  Calculated Creatinine Clearance = (140-age) X actual body wt.(kg) 72 X serum
             creatinine. Multiply this number by 0.85 if the patient is female.

          -  Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities. Prior to study entry, any ECG
             abnormality at screening has to be documented by the investigator as not medically
             relevant. Patients must not have history of congestive heart failure of any grade
             according to Heart Association (NYHA) (see Appendix 2).

          -  Age > 18 years and capacity to give informed consent.

          -  All patients must have given signed, informed consent prior to registration to the
             study.

        Exclusion Criteria:

          -  No prior chemotherapy for recurrent / metastatic adenoid cystic carcinoma. Up to 1
             prior biologic/targeted therapy regimen is allowed. Also, chemotherapy as part of
             initial potentially curative therapy (i.e. concurrent chemoradiotherapy) is allowed,
             if it was completed >6 months earlier.

          -  Patients must not have any prior anthracyclines (doxorubicin, epirubicin,
             daunorubicin, idarubicin) or mitoxantrone, or bortezomib.

          -  No history of prior malignancy, with the exception of curatively treated squamous cell
             or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year
             disease-free interval.

          -  Patients must not have history of allergic reactions attributed to compounds of
             similar chemical or biologic composition to bortezomib, boron or mannitol.

          -  Patients must not have any pre-existing neuropathy of grade > 1.

          -  Patients must not have uncontrolled intercurrent illness including, but not limited
             to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          -  Female patients who are pregnant or breast feeding or patients of reproductive
             potential not using an effective method of birth control will be excluded. Women of
             childbearing potential must have a negative serum pregnancy test within 2 weeks of the
             first administration of chemo. Also, male patients whose sexual partners are women of
             child bearing potential not using effective birth control will be excluded.

          -  Patients with known positivity for human immunodeficiency virus (HIV) will be excluded
             due to possible pharmacokinetic interactions with bortezomib. Appropriate studies will
             be undertaken in HIV-positive patients who are receiving or not receiving combination
             anti-retroviral therapy when indicated.

          -  Patient must not have received other investigational drugs within 14 days before
             enrollment.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Athanassios E Argiris, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00581360

Organization ID

06-124


Responsible Party

Sponsor

Study Sponsor

University of Pittsburgh

Collaborators

 Millennium Pharmaceuticals, Inc.

Study Sponsor

Athanassios E Argiris, MD, Principal Investigator, Principal Investigator


Verification Date

September 2016