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

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)

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.

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