BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC

Lung Cancer Clinical Trial

Official title: A Phase II, Open Label Study of ZD6474 in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Status Completed

Clinical Trial Summary

Primary Objective:

• To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.

Secondary Objectives:

• Determine the overall response rate

• Determine the overall survival

• Determine the time to disease progression

• Assess the safety/toxicity of the study treatment

• Assess biomarker modulation in the tumor tissue and serum samples from the treatment

• Assess plasma and intra-tumor concentrations of study treatment

Clinical Trial Description

ZD6474 is designed to block the formation of new blood vessels. The growth of new blood vessels is called angiogenesis. Angiogenesis is thought to be important for the growth of tumors beyond a small size. Researchers want to find out if ZD6474 will limit new blood vessel growth in the tumor and "starve" the tumor by limiting blood flow to it.

In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823 are assigned to one of the research studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study.

While on study, you will take ZD6474 by mouth each morning. ZD6474 is swallowed as a whole tablet. The tablet should not be chewed, crushed, or divided and should be taken with 8 ounces of water and a small amount of food to lessen stomach discomfort. You should take ZD6474 at about the same time every day. Four (4) weeks is considered 1 treatment cycle. If you miss a dose and are unable to take the missed dose on the same day, you should take the next scheduled dose and the missed dose will not be made up. The dose of study medication may be repeated if vomiting occurs within 30 minutes of taking the study medication.

You will have routine blood tests (about 2 teaspoons) at Weeks 1, 2, 4, 8, 12, then every 4 weeks after that. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart) at Weeks 1, 2, 4, 8, 12, then every 3 months after that. Every 4 weeks, your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), a performance status evaluation, and weight. You will also have a routine urine test and your study doctor will ask you about any medications you are taking and your smoking history.

Every 2 cycles, your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking coumadin, you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function every week. You will be asked to bring your unused medication to each clinic visit.

You may continue receiving ZD6474 for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects, your medical condition gets worse, and/or you are unable to comply with study requirements. If you stop study treatment, you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program.

After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, chest x-ray, ECG, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years to see how you are doing.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse.

This is an investigational study. ZD6474 is an investigational drug that has been approved by the FDA for research use only. Up to 72 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson. ;

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 Cancer
• Lung Neoplasms

• NCT number: NCT00410189
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: November 2006
• Completion date: March 2013