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Lung CancerPhase 2NCT00410189

BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC

A Phase 2 study testing ZD6474 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
ZD6474
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Nov 2006to Mar 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
  • 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).
  • The patient has uni-dimensionally measurable NSCLC.
  • Karnofsky performance status >/= 60 or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • The patient has biopsy accessible tumor.
  • 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.
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  • 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.
  • 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.
  • The patient has prothrombin time (PT) < 1.5 times upper limit of normal
  • 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.
  • The patient is >/= 18 years of age.
  • The patient has signed informed consent.
  • The patient is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt from exclusion.
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.
  • Subject must be considered legally capable of providing his or her own consent for participation in this study.

Who cannot join

  • The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug
  • The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.
  • 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.
  • 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.
  • The patient has uncontrolled seizure disorder, active neurologic disease, or neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are eligible for the study if the above exclusion criteria are not met.
  • The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
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  • Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment
  • The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).
  • 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.
  • 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.
  • Patients may not have a history of a bleeding diathesis.
  • Significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >/=2 within 3 months of entry of presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia
  • History of clinically significant arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or a symptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
  • Prior history of QT prolongation as a result from other medication that required discontinuation of that medication.
  • Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
  • QTc with Bazett's correction that is unmeasurable, or >/=480 msec on screening ECG. If a patient has QTc >/=480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the patient to be eligible for the study). If the patient meets eligibility requirements in this way, the "baseline" QTc for this patient will be the average of the 3 ECGs (screen 1, screen 2, and pre-1st dose). Patients who are receiving a drug that has a risk of QTc prolongation are excluded if QTc is >/= 460 msec.
  • Any concomitant medications that affect QTc, induce Torsades de Pointes. (lists of relevant medications available that have a risk of Torsades de Pointes or QTc prolongation.) Drugs listed that in the investigator's opinion cannot be discontinued, are allowed however, must be monitored closely.
  • Potassium, calcium (ionized calcium or adjusted for albumin), or magnesium concentrations outside normal limits. Supplementation of electrolytes is permitted. Potassium level must be greater than or equal to 4.0 meq/L.
  • Concomitant medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function.
  • Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
  • Presence of left bundle branch block (LBBB.)
  • Any unresolved toxicity greater than common terminology criteria (CTC) grade 1 from previous anti-cancer therapy.
  • Currently active diarrhea that may affect the ability of the patient to absorb the ZD6474 or tolerate diarrhea.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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
Read the 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.

Conditions
Lung Cancer
Being tested
ZD6474
Keywords
Non-Small Cell Lung Cancer, NSCLC, Lung Cancer, ZD6474, Zactima, Vandetanib, BATTLE Program
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZD6474Drug

    Also called Zactima, Vandetanib

    300 mg by mouth daily for 28 Days.

Study groups in NCT00410189
Study groupRoleWhat they receive
ZD6474ExperimentalZD6474 300 mg by mouth daily for 28 Days.
Receives: Drug: ZD6474

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)

    The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

    Measured: Baseline to 8 Weeks

Secondary outcomes (1)

  1. 8 Week Progression-Free Survival

    Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.

    Measured: Every 8 weeks till disease progression.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410189
Sponsor's protocol ID
2005-0825
Status last verified
Mar 2015
First submitted
8 Dec 2006
Last updated
23 Mar 2015
Data monitoring committee
Yes

Publications

  • Tam AL, Kim ES, Lee JJ, Ensor JE, Hicks ME, Tang X, Blumenschein GR, Alden CM, Erasmus JJ, Tsao A, Lippman SM, Hong WK, Wistuba II, Gupta S. Feasibility of image-guided transthoracic core-needle biopsy in the BATTLE lung trial. J Thorac Oncol. 2013 Apr;8(4):436-42. doi: 10.1097/JTO.0b013e318287c91e.

    PubMed 23442309

  • Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, Stewart DJ, Hicks ME, Erasmus J Jr, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011 Jun;1(1):44-53. doi: 10.1158/2159-8274.CD-10-0010. Epub 2011 Jun 1.

    PubMed 22586319

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZD6474 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease) (time frame: Baseline to 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410189, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.

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