Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases

Study Overview
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Brief Summary
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A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.

Official Title
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A Phase I Study of ZD6474 (Vandetanib) Concurrent With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Patients With Non-small Cell Lung Cancer (NSCLC)

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: ZD6474 (Vandetanib)
* Radiation: Whole Brain Radiotherapy (WBRT)
* Drug: ZD6474
* Drug: ZD6474


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged above 18 years with histologically or cytologically confirmed NSCLC and contrast-enhanced CT scan or Gadolinium-enhanced MRI confirmed brain metastases who have a performance status of 0 to 2 No previous radiotherapy, surgery or chemotherapy for brain metastases Patients should not have any unstable systemic disease Exclusion Criteria: Serious abnormal laboratory values Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol Clinically 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 before entry; or presence of cardiac disease that, in the Previous randomization of treatment in the present study and/ or current participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZACTIMA TM<br> | Drug: ZD6474 (Vandetanib)<br>* 100 mg as a once daily oral dose, 21 days<br>* Other names: ZACTIMA TM;Radiation: Whole Brain Radiotherapy (WBRT)<br> <br> Drug: ZD6474<br>* 200 mg as a once daily oral dose, 21 days<br>* Other names: ZACTIMA TM;Drug: ZD6474<br>* 300 mg as a once daily oral dose, 21 days<br>* Other names: ZACTIMA TM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases |  | All evaluable patients (all registered patients who receive at least opne dose of study medication) who have completed week 9 study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the time to clinical and radiological progression of brain metastases |  | Until disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer (NSCLC), Whole Brain Radiotherapy, metastasis