Clinical trial NCT00193284: Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Aventis Pharmaceuticals
First posted: 2005-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Overall survival
measure: Time to progression
measure: Overall toxicity
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.