NCT00193284

Brief Summary

Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel combination of chemotherapy, radiation therapy, and gefitinib.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Oct 2003

Typical duration for phase_2 head-and-neck-cancer

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

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 22, 2010

Status Verified

January 1, 2009

Enrollment Period

2.3 years

First QC Date

September 12, 2005

Last Update Submit

June 18, 2010

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Secondary Outcomes (3)

  • Overall survival

  • Time to progression

  • Overall toxicity

Interventions

GefitinibDRUG
DocetaxelDRUG
CarboplatinDRUG
FluorouracilDRUG

Eligibility Criteria

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

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Squamous carcinoma of the head and neck.
  • Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx
  • Squamous carcinoma in cervical nodes no identified primary site
  • Must be considered to have low cure rates with local therapy
  • Previously untreated with chemotherapy or radiation therapy.
  • Able to perform activities of daily living without assistance
  • Adequate bone marrow, liver, and kidney function
  • Mild peripheral neuropathy is allowed
  • Measurable or evaluable disease
  • Voluntarily give written informed consent.

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Age \< 18 years
  • History of prior malignancy within the last five years
  • Severe or uncontrolled systemic disease
  • Significant clinical disorder or laboratory finding
  • Women who are pregnant or breast-feeding
  • Active interstitial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related Publications (1)

  • Hainsworth JD, Spigel DR, Burris HA 3rd, Markus TM, Shipley D, Kuzur M, Lunin S, Greco FA. Neoadjuvant chemotherapy/gefitinib followed by concurrent chemotherapy/radiation therapy/gefitinib for patients with locally advanced squamous carcinoma of the head and neck. Cancer. 2009 May 15;115(10):2138-46. doi: 10.1002/cncr.24265.

    PMID: 19288572RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

GefitinibDocetaxelCarboplatinFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • John D. Hainsworth, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 2003

Primary Completion

February 1, 2006

Study Completion

January 1, 2009

Last Updated

June 22, 2010

Record last verified: 2009-01

Locations

US(1)