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Head and Neck CancerPhase 2NCT00193284

Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

A Phase 2 study testing Gefitinib, Docetaxel and Carboplatin in people with Head and Neck Cancer, run by SCRI Development Innovations, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Gefitinib, Docetaxel and Carboplatin
How many people
50 participants
Where
1 siteUnited States
Study dates
Oct 2003to Jan 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

Other trials in United States

About this study

Official title: A Phase I/II Trial of Induction Chemotherapy Plus Gefitinib (Iressa) Followed by Concurrent Chemotherapy, Radiation Therapy, and Gefitinib (Iressa) For Patients With Locally Advanced Squamous Carcinoma of the Head and Neck

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.

Read the detailed description

Upon determination of eligibility, patients will receive:

Induction Therapy

  • Docetaxel
  • Carboplatin
  • 5-FU
  • Gefitinib

Combined Modality Therapy

Cohort 1:

  • Radiation therapy
  • Gefitinib

Cohort 2:

  • Radiation therapy
  • Gefitinib
  • Docetaxel
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

Secondary outcomes (3)

  1. Overall survival

  2. Time to progression

  3. Overall toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2006
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193284
Sponsor's protocol ID
SCRI HN 04
Other IDs
IRUSIRES0047, IIT 15038
Status last verified
Jan 2009
First submitted
12 Sep 2005
Last updated
22 Jun 2010
Results posted
No

Publications

  • 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.

    PubMed 19288572

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefitinib, Docetaxel and Carboplatin in people with Head and Neck Cancer, run by SCRI Development Innovations, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00193284, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.

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