NCT00305734

Brief Summary

This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

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

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

March 21, 2006

Last Update Submit

January 24, 2013

Conditions

Recurrent Nasopharyngeal CancerStage IV Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (2)

  • Objective response rate (confirmed and unconfirmed, complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST) in patients treated with bortezomib

    Up to 3 years

  • Progression-free survival rate

    3 months

Secondary Outcomes (6)

  • Response probability (confirmed and unconfirmed, complete and partial response) based on the RECIST in patients treated with bortezomib and gemcitabine hydrochloride

    Up to 3 years

  • Progression-free survival rate

    6 months

  • Progression-free survival rate

    1 year

  • Adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

    Up to 3 years

  • Overall survival

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Treatment (bortezomib, gemcitabine hydrochloride)

EXPERIMENTAL

Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses of treatment with bortezomib. Patients who experience disease progression on single-agent bortezomib and did not receive prior gemcitabine hydrochloride may begin combination therapy within 10-28 days of the last dose of bortezomib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and bortezomib IV on days 1, 4, 8, 11. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond the confirmed CR.

Drug: bortezomibDrug: gemcitabine hydrochlorideOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

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

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (bortezomib, gemcitabine hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib, gemcitabine hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed nasopharyngeal carcinoma (NPC) of one of the following subtypes:
  • Non-keratinizing (WHO type II)
  • Undifferentiated (WHO type III)
  • Disease meets one of the following stage criteria:
  • Stage IVC at diagnosis
  • Persisted, metastasized, or recurred after definitive surgery, radiotherapy, and/or chemotherapy
  • Measurable disease
  • If only measurable disease is within a prior radiation therapy port, disease progression must be clearly demonstrated
  • No known CNS metastases
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • SGOT or SGPT ≤ 2.5 times ULN
  • Zubrod performance status 0-2
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

BortezomibGemcitabine

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

Study Officials

  • Stephen Shibata

    SWOG Cancer Research Network

    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

March 21, 2006

First Posted

March 22, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2007

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)