NCT00077428

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 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

3 years

First QC Date

February 10, 2004

Last Update Submit

January 23, 2013

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Salivary Gland CancerSalivary Gland Adenoid Cystic CarcinomaStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Salivary Gland CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Salivary Gland Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective tumor response (complete and partial overall response) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 10 years

Secondary Outcomes (5)

  • Toxicities, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

    Up to 30 days after last dose of study treatment

  • Progression free survival

    Time from randomization or registration to the earlier of disease recurrence or death from any cause, assessed up to 10 years

  • Overall survival

    Time from randomization or registration to date of death (from any cause) or date of last contact, assessed up to 10 years

  • Association of change in cytokine concentration with response to bortezomib therapy

    Up to 1 hour post-treatment (course 2)

  • Correlation of the expression of biomarkers which may be affected by the ubiquitin-proteasome degradation pathway on tumor tissue with clinical activity

    Baseline

Study Arms (1)

Treatment (bortezomib, doxorubicin hydrochloride)

EXPERIMENTAL

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.

Drug: bortezomibDrug: doxorubicin hydrochlorideOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (bortezomib, doxorubicin hydrochloride)
doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Treatment (bortezomib, doxorubicin hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib, doxorubicin hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

BortezomibDoxorubicin

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Athanassios Argiris

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 12, 2004

Study Start

June 1, 2004

Primary Completion

June 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)