Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Laryngeal Diseases

Oral Squamous Cell Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Cisplatin

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

ZD1839 (IRESSA)

Radiation Therapy

Roger Keresztes, M.D.

The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.

This is a Phase I-II, open-label, dose-escalation study in subjects with advanced head or neck cancer. Subjects will receive daily ZD1839 during a course of standard radiation therapy accompanied by cisplatin.

Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, who are in medically stable condition, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of £ 1, stable hepatic and bone marrow function, and a life expectancy of at least 6 months. Subjects should have no previous cancer history (with the exception of squamous cell carcinoma of the skin or cervical cancer in situ) and no prior treatment with radiation, chemotherapy, or definitive surgical therapy. Subjects in the Phase II portion of the trial must have measurable disease as defined by RECIST criteria.

Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer

Phase I-II Study of ZD1839 (IRESSA®), Cisplatin, and External-Beam Radiation Therapy in Patients With Locally Advanced, Non-Metastatic, Squamous Cell Carcinoma of the Head and Neck

Weill Medical College of Cornell University

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Iressa plus thoracic RT at the following dose levels:

* Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
* Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
* Level 3: 63.0 Gy in 15 fractions of 4.2 Gy

ZD1839 (Iressa)

Thoracic Radiotherapy

Maria Werner-Wasik, MD

The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.

To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.

To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.

ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer

A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer

See "Adverse Events" section for specific toxicities

Definitions of objective tumor response

* Complete response - disappearance of all target lesions
* Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
* Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
* Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started

AstraZeneca

Sidney Kimmel Cancer Center at Thomas Jefferson University

Iressa plus thoracic RT at the following dose levels:

* Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
* Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
* Level 3: 63.0 Gy in 15 fractions of 4.2 Gy

ZD1839 (Iressa)

Thoracic Radiotherapy

Iressa and RT

Age, Continuous

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Patients Affected by Treatment-related Morbidities

Complete response

Partial response

Minor response

Stable disease

Progressive disease

Not evaluable

Tumor Response

Progression-free Survival

Survival From Starting Gefitinib

Overall Study

Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.

Yuri Rukazenkov

The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.

Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment

Symptoms and General Pathology

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

ZD1839: 250mg/day po or via g-tube Q 24 hours

Ezra Cohen, M.D.

The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's squamous cell head and neck cancer. The research is being done because currently no effective treatment exists for metastatic (spread of cancer cells from one area of the body to another) or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.

A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma

University of Chicago

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer	NCT00195078	Head and Neck C...	ZD1839 (IRESSA) Cisplatin Radiation Thera...	18 Years -	Weill Medical College of Cornell University
ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer	NCT00328562	Non-Small Cell ...	ZD1839 (Iressa) Thoracic Radiot...	18 Years -	Thomas Jefferson University
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment	NCT00683306	Non Small Cell ...	ZD1839 (Iressa)	18 Years - 130 Years	AstraZeneca
A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma	NCT01185158	Head and Neck C...	ZD1839 (IRESSA)	18 Years -	University of Chicago
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment	NCT00683306	Non Small Cell ...	ZD1839 (Iressa)	18 Years - 130 Years	AstraZeneca
A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma	NCT01185158	Head and Neck C...	ZD1839 (IRESSA)	18 Years -	University of Chicago

Spots Global Cancer Trial Database for zd1839 (iressa)