ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00328562 |
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Recruitment Status :
Completed
First Posted : May 22, 2006
Results First Posted : August 11, 2014
Last Update Posted : November 29, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Carcinoma (NSCLC) | Drug: ZD1839 (Iressa) Radiation: Thoracic Radiotherapy | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | December 2003 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | September 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Iressa and RT
Iressa plus thoracic RT at the following dose levels:
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Drug: ZD1839 (Iressa) Radiation: Thoracic Radiotherapy |
- Patients Affected by Treatment-related Morbidities [ Time Frame: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy ]See "Adverse Events" section for specific toxicities
- Tumor Response [ Time Frame: Baseline, 1, 3, and 5 months post-treatment ]
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
- Progression-free Survival [ Time Frame: Baseline to date of progression ]
- Survival From Starting Gefitinib [ Time Frame: Baseline to date of expiration ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed non small cell lung cancer
- Stage IV needing radiation therapy to control symptoms
- Patients with brain metastases
- Unresectable or medically inoperable
Exclusion Criteria:
- Small cell lung cancer
- Previous thoracic radiation therapy
- Oxygen-dependent patients
- Forced expiratory volume in 1 second (FEV1) less than 1.5
- Patients with active interstitial lung disease
- Patients with underlying lung disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328562
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | Maria Werner-Wasik, MD | Thomas Jefferson University |
Additional Information:
| Responsible Party: | Sidney Kimmel Cancer Center at Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00328562 History of Changes |
| Other Study ID Numbers: |
03C.225 2003-07 ( Other Identifier: CCRRC ) |
| First Posted: | May 22, 2006 Key Record Dates |
| Results First Posted: | August 11, 2014 |
| Last Update Posted: | November 29, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
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Advanced NSCLC Non-Small Cell Lung Carcinoma Stage IV NSCLC |
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Gefitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |