Radiation Therapy (XRT) and ZD6474 in Non-Small Cell Lung Cancer (NSCLC): Phase II

Non-Small Cell Lung Cancer Clinical Trial

Official title: A Phase 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

Status Withdrawn

Clinical Trial Summary

Primary Objectives:

• To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity, and duration of treatment-emergent adverse events in patients with poor prognosis lung cancer.

• To record the extent, frequency and duration of any tumor responses to this treatment regimen and assess whether ZD6474 augments the efficacy of radiation therapy in non-small cell lung cancer patients.

• To determine the recommended phase II dose of ZD6474 for future clinical studies with radiation therapy.

Secondary Objectives:

• To determine the effects on metabolism and angiogenic factors by positron emission tomography (PET) scan/computed tomography (CT) scan , Vascular endothelial growth factor (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and radiation therapy.

Clinical Trial Description

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 UT MD Anderson Cancer Center (MDACC). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

• NCT number: NCT02087839
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2008
• Completion date: September 2012