The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

Study Overview
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Brief Summary
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This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

Official Title
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An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)

Conditions
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Carcinoma, Non-Small-Cell Lung Carcinoma, Head and Neck Neoplasms

Intervention / Treatment
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* Drug: AZD2171


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC) At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease Exclusion Criteria: NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171 HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171 Untreatable, unstable brain or meningeal metastases. Abnormal liver and kidney blood chemistries History of poorly controlled hypertension with resting blood pressure of >150/100 Recent (< 14 days) major surgery or a surgical incision not fully healed Diabetes patients with type I insulin dependent diabetes or poorly controlled type II Significant hemorrhage or hemoptysis Presence of necrotic/hemorrhagic tumor or metastases

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|oral tablet|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) | Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100 | Randomisation until Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Arterial Blood Pressure (MAP) | Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline). | Randomisation until Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RECENTIN