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Sponsors and Collaborators: |
M.D. Anderson Cancer Center AstraZeneca |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00745732 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: ZD6474 (ZACTIMA) Radiation: Radiation Therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Dose-Escalation and Safety Study of ZD6474 (ZACTIMA) Used In Combination With Radiation Therapy for Patients With Inoperable/Unresectable Non-Small Cell Lung Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Radiation Therapy + ZD6474: Experimental |
Drug: ZD6474 (ZACTIMA)
ZD6474 (ZACTIMA) beginning at 100 mg once a day by mouth
Radiation: Radiation Therapy
Phase I: 45 Gy at 3 Gy per fractions once a day. Phase II: 45 Gy at 3 Gy per fraction once a day or 66-70 Gy at 2 Gy per fraction once a day. |
ZD6474 is a new drug that is thought to block the formation of new blood vessels. The growth of new blood vessels is called angiogenesis. Angiogenesis is thought to be essential for the growth of tumors beyond a small size.
Before treatment starts, you will have several tests and procedures performed. These tests will include a complete medical history and physical exam, including recent weight loss, vital signs, and a test to check how easily you swallow. Laboratory tests needed will require a urine sample, and blood samples (about 3-4 teaspoons). Women who are able to have children must have a negative blood pregnancy test in order to participate in this study. You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart), heart function tests, and scans of your brain, chest, and bones. You will also have PET scans performed.
You may take part in this study if you are a patient with NSCLC who is not able to receive chemotherapy.
If you are eligible to participate, you will receive ZD6474 by mouth once a day every day, along with radiation therapy. You must take your medication on an empty stomach, at approximately the same time each morning. ZD6474 should be swallowed as a whole tablet (not chewed, crushed or divided) and taken with 8 oz of water. Missed doses may be taken by the end of the same calendar day. However, if a subject misses taking their scheduled dose on the same day, he or she must take the next scheduled dose and the missed dose will not be made up. The missed dose must be documented on patients medication diary ZD6474 will be given 5-7 days before starting radiation therapy and will continue through the entire course of radiation therapy, unless there is proof that the cancer is progressing. ZD6474 may interact with many commonly prescribed medications. A list will be provided to you.
Radiation will be given every weekday (Monday - Friday) for 3-7 weeks as your doctor thinks is necessary and useful. You will have weekly evaluations during radiation treatment, including blood samples (3-4 teaspoons) for routine testing, oxygen saturation (a test that measures how much oxygen is in the blood), and physical examination.
If you need anti-nausea medication (such as Zofran) during this study, you will have an ECG performed within 24 hours of starting the medication and then again at least once a week while you remain on the medication.
You will continue on study, unless there is evidence that the disease has gotten worse or intolerable side effects occur.
You will be seen for a follow-up visit one month after completing radiation therapy, and again at 3 months. You will then come in for a follow-up visit every 3 months for 2 years, then every 6 months for 3 years, then once a year. Scheduled tests and follow-ups should be performed within 1 week (before or after) of the scheduled time period (a 14-day window). At these visits, you will have blood draws (about 3-4 teaspoons), urine tests and x-rays. You will have an ECG, lung function tests, and PET/CT scans.
Participants who are blood donors should not donate blood during the study and for 3 months following their last dose of study treatment.
This is an investigational study. ZD6474 is not FDA approved, and has been authorized for research only. A total of up to 48 patients will take part in this study. All patients will be enrolled at UTMDACC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melenda D. Jeter, MD, MPH | 713-792-0863 | |
Contact: Toni Williams | 713/563-2361 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Donna Reeves | |
Principal Investigator: Melenda D. Jeter, MD, MPH |
Principal Investigator: | Melenda D. Jeter, MD, MPH | Assistant Professor, UT MDACC |
Responsible Party: | U. T. M. D. Anderson Cancer Center ( Melenda D. Jeter MD, MPH/Asst Professor ) |
Study ID Numbers: | 2003-0787 |
Study First Received: | September 2, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00745732 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Lung Cancer NSCLC ZD6474 ZACTIMA Vandetanib |
Inoperable NSCLC Unresectable NSCLC Radiation Therapy Palliative radiation therapy Angiogenesis |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |