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BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC

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

NCT00410189•M.D. Anderson Cancer Center

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
•2. The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen. (Patients who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in study).
•3. The patient has uni-dimensionally measurable NSCLC.
•4. Karnofsky performance status \>/= 60 or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•5. The patient has biopsy accessible tumor.
•6. The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) \>/= 1,500/mm\^3, platelet count \>/= 100,000/mm\^3, White Blood Count (WBC) \>/= 3,000/ mm\^3, and hemoglobin \>/= 9 g/dL.
•7. The patient has adequate hepatic function as defined by a total bilirubin level \</= 1.5 times the upper limit of normal, and alkaline phosphatase, Alanine aminotranferease (ALT) or aspartate aminotransferase (AST) \</= 2.5 times the upper limit of normal.
•8. The patient has adequate renal function as defined by a serum creatinine level \</= 1.5 mg/dL or a calculated creatinine clearance of \>/= 60cc/minute.
•9. The patient has prothrombin time (PT) \< 1.5 times upper limit of normal
•10. If patient has brain metastasis, they must have been stable (treated or asymptomatic) for at least 4 weeks after radiation if treated with radiation and not have used steroids for at least 1 week. Re-imaging performed after 2 weeks, upon completion of radiation therapy.
+4 more criteria

Exclusion Criteria

•1. The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug
•2. The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.
•3. The patient has received radiation therapy to the measurable tumor within 6 months. Patients are allowed to have local irradiation for the management of tumor-related symptoms (bones, brain). However, if a patient has active new disease growing in the previously irradiated site, the patient will be eligible to participate in the study.
•4. The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e. currently treated with antibiotics), uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.
•6. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
•7. Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment
•8. The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).
•9. Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy. However, the patient will be excluded from a given study if he/she has received the same therapy as the clinical trial (i.e. If a patient has been previously treated with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been previously treated with erlotinib, they are excluded from the clinical trials with erlotinib). In addition, if a patient has been previously treated with gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.
•10. Patients must not have undergone minor surgery (e.g., central venous catheter placement) within 24 hours of treatment with ZD6474. Patients may not have undergone any major surgery (e.g. laparotomy, thoracotomy, or craniotomy) within four weeks of enrollment.
•11. Patients may not have a history of a bleeding diathesis.
+12 more criteria

Locations (1)

UT MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2013

Last Updated

March 23, 2015

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

ZD6474

DRUG

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

NCT06498635

Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8+2 more

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NCT06066138

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC

Inclusion Criteria

Exclusion Criteria

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