A Phase 2 interventional study of ZD6474 in Lung Cancer and Pleural Effusion, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn the effect of ZD6474 on the amount of time between placement of an indwelling pleural catheter and the catheter's removal in patients with malignant pleural effusion.
This study will also look at the effect that ZD6474 has on tumor cells, biological characteristics of cells in the body, rate of fluid build-up around the lungs, tumor size, and thickness of blood vessels. The effect that this drug has on quality of life and shortness of breath will also be examined.
ZD6474 is an investigational drug that has not yet received approval from the FDA. ZD6474 is designed to limit VEGF. Vascular endothelial growth factor (VEGF) is considered to play a key role in the development of pleural effusion. Pleural effusion is an abnormal collection of pleural fluid in the pleural lining surrounding the lungs. The pleural lining is the thin covering that protects and cushions the lungs. It is made up of two layers of tissue that are separated by a small amount of fluid.
ZD6474 has shown promising activity against a number of cancers in laboratory tests in animals with cancer and in some early clinical trials in patients with non-small cell lung cancer (NSCLC). ZD6474 has also demonstrated significant reduction in pleural effusion in association with VEGF inhibition of tumor cells in mice with lung tumors and pleural effusion. It is hoped that ZD6474 will decrease the amount of pleural effusion that occurs in NSCLC patients. In addition, ZD6474 is thought to block the formation of new blood vessels, which may limit new blood vessel growth in the tumor and "starve" the tumor.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight. You will be asked questions about your ability to perform daily activities (performance status evaluation). You will have blood (about 2-3 teaspoons) drawn for routine tests. You may have up to 3 electrocardiograms (ECG --a test that measures the electrical activity of the heart). You will also have a chest x-ray and computed tomography (CT) scans of your chest to measure the status of the disease. You will be asked to fill out 2 questionnaires about the quality of your life and shortness of breath. The questionnaires will take about 10-15 minutes, total, to complete. Women who are able to have children must have a negative blood (about 1-2 teaspoons) pregnancy test.
If you are found to be eligible to participate in the study, you will have an indwelling intrapleural catheter placed. You will have to sign a separate consent document before placement of an indwelling intrapleural catheter can be performed. The pleural fluid will be collected at each clinic visit. The fluid will be saved and analyzed to answer research questions that are part of this study. You will also need to drain your pleural fluid everyday. The research nurse will provide you with instructions on how to drain your daily pleural fluid and a patient "diary" to take home to record the amount of fluid drained every day. The study doctor or research nurse will review the diary at each clinic visit.
After placement of the intrapleural catheter (Day 1), you will receive treatment with ZD6474. Treatment on this study is for 10 weeks. You will take a ZD6474 tablet by mouth each morning. The tablet should not be chewed, crushed, or divided, and should be taken with 8 ounces of water. You should take the tablet at about the same time every day.
During your participation on this study, you will have a physical exam, routine blood tests and chest x-ray at Weeks 2, 6, and 10. At Weeks 6 and 10, you will also have a CT scan. You will have an ECG at Weeks 1, 2, 4, and 8. Your doctor may decide to have additional ECGs to monitor your condition or if you experience a heart rate of less than 50 at any time during study participation. You will also be asked to complete 2 questionnaires about the quality of your life and any shortness of breath you are experiencing. You will complete these questionnaires at home and return them to the research staff at each clinic visit. You will be asked to record your weekly blood pressure for the first 6 weeks of study treatment. The study doctor or research nurse will review the log at each clinic visit.
If you are benefitting from the study treatment and your doctor feels that it is your best interest, you may continue to receive the study drug longer than 10 weeks. During your participation in this extended treatment phase, every 4 weeks you will have a physical exam and your performance status will be evaluated. You will have blood (about 2-3 teaspoons) drawn for routine tests. Every 4 weeks, you will have ECGs performed. You will also have a chest x-ray and computed tomography (CT) scans of your chest to measure the status of the disease every 8 weeks. Your study drug will continue to be provided to you.
You may be taken off study early if you have intolerable side effects or the disease gets worse.
This is an investigational study. ZD6474, the investigational drug to be used in this study, is not approved by the FDA for commercial use; however, the FDA has permitted its use in this research study. Up to 25 patients will take part in this study. All will be enrolled at M. D. Anderson.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
300 mg/day orally for 10 weeks.
Drug: ZD6474
300 mg/day orally for 10 weeks.
Also known as: Vascular Endothelial Growth Factor Receptor, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
Median Time to Pleurodesis
Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.
Time frame: Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks
Recruitment Period: October 2006 to July 2010 at UT MD Anderson Cancer Center included NSCLC participants diagnosed with proven metastatic disease to the pleural space by pleural fluid cytology or pleural biopsy and required IPC placement because of symptomatic recurrent pleural effusions between May 2007 and February 2010.
| Milestone | ZD6474 |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.
| Days | ZD6474 |
|---|---|
| Median Time to Pleurodesis | 35 (15 to NA) |
Collected over Adverse event collection for 10 week treatment period. Collection period: May 2007 to February 2010.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZD6474 | — | 12/20 (60%) | 20/20 (100%) |
| Event | ZD6474 |
|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 3/20 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/20 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 3/20 |
| Atrial FibrillationCardiac disorders | 2/20 |
| R. PneumothoraxInfections and infestations | 2/20 |
| HyponatremiaMetabolism and nutrition disorders | 2/20 |
| CNS IschemiaNervous system disorders | 1/20 |
| CreatinineRenal and urinary disorders | 1/20 |
| DiarrheaGastrointestinal disorders | 1/20 |
| PainGeneral disorders | 1/20 |
| Event | ZD6474 |
|---|---|
| DiarrheaGastrointestinal disorders | 12/20 |
| FatigueGeneral disorders | 7/20 |
| Weight lossGeneral disorders | 5/20 |
| Prolonged QTcCardiac disorders | 5/20 |
| HypomagnesemiaBlood and lymphatic system disorders | 5/20 |
| Erythema multiformeSkin and subcutaneous tissue disorders | 4/20 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 4/20 |
| HypokalemiaBlood and lymphatic system disorders | 4/20 |
| NauseaGastrointestinal disorders | 3/20 |
| Cardiac arrhythmiaCardiac disorders | 3/20 |
| Age, Continuous(years) | ZD6474 |
|---|---|
| Median | 72 (46 to 80) |
| Sex: Female, Male(Participants) | ZD6474 |
|---|---|
| Female | 9 |
| Male | 11 |
| Region of Enrollment(participants) | ZD6474 |
|---|---|
| United States | 20 |
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center