NCT00212108

Brief Summary

EGFR and COX-2 are involved in tumorigenesis, angiogenesis and metastases and are frequently over expressed in NPC.COX-2 and EGFR inhibitors are active in NPC.There is synergistic action between COX-2 and EGFR inhibitors. Study hypothesis: Celecoxib and gefitinib can reduce angiogenesis and induce anti-tumorigenicity in patients with nasopharngeal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

March 29, 2012

Conditions

Nasopharyngeal Carcinoma

Keywords

celecoxib, NPC, gefitinib

Outcome Measures

Primary Outcomes (1)

  • To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.

    1 year

Secondary Outcomes (2)

  • To evaluate the safety profile of celecoxib and ZD1839.

    30 days

  • To assess the pharmacokinetics of ZD1839 and celecoxib.

    30 days

Study Arms (1)

Celecoxib and ZD1839

EXPERIMENTAL

Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.

Drug: celecoxib, gefitinib

Interventions

celecoxib, gefitinibDRUG

The dose of ZD1839 to be administered is 250mg. ZD1839 will be taken once daily in the morning at approximately the same time each day. If the patient inadvertently did not take the dose in the morning, the patient may take that dose anytime up to 10pm that same day. The daily treatment will be resumed the next day at the scheduled morning dose. Celecoxib will be administered at 400 mg bd.

Also known as: ZD1839 (Iressa™)
Celecoxib and ZD1839

Eligibility Criteria

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

You may qualify if:

  • Histologically proven NPC.
  • Any clinical stage NPC as defined by the AJCC/UICC System.
  • No prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
  • No prior NSAIDs or corticosteroids for at least 4 weeks.
  • ECOG performance status ≤ 2.
  • Adequate end organ function
  • Life expectancy \> 3 months.
  • Signed informed consent -

You may not qualify if:

  • Inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
  • Tumor not visible on fibre nasopharyngoscopy for biopsy.
  • Known peptic ulcer disease.
  • Evidence of clinically active interstitial lung disease.
  • Previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
  • Women who are pregnant or lactating. Females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
  • Women of childbearing potential who are not practising adequate contraception.
  • Concurrent medical problems that would significantly limit compliance with the study.
  • Presence of any underlying medical conditions (eg. Unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
  • Known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of NSAIDs.
  • Known HIV, HBV or HCV infection. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

CelecoxibGefitinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ross Soo, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ross Soo

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2003

Primary Completion

March 1, 2007

Study Completion

January 1, 2009

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

SG(1)