| Exclusion Criteria: | 1) Have received more than 2 previous chemotherapy regimens for NSCLC or have received the last chemotherapy agent within 28 days of the first dose of AZD2171. Previous chemotherapy for HNC if received with 28 days of first dose of AZD2171. Radiotherapy for HNC or NSCLC is not permissible within 28 days prior to dosing. If possible, the tumor biopsy should be outside of the radiotherapy field.
2) Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either - do not require corticosteriods, or - have been treated with corticosteriods, with clinical and radiological evidence of brain metastases stabilisation at least 10 days after discontinuation of steriods.
3) Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count </= 1.5 x 10^9/L or platelet count </= 100 x 10^9/L or requiring regular blood transfusions to maintain Haemoglobin > 9 g/dl
4) Serum bilirubin >/=1.5 x ULRR
5) ALT or AST >/=2.5 x ULRR. If liver metastases are present, ALT or AST > 5 x ULRR
6) Serum creatinine >1.5 x ULRR or a creatinine clearance of </=50mL/min calculated by Crockroft-Gault
7) Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein < 1.5 g in a 24 hour period.
8) History of significant gastrointestinal impairment, as judged by the investigator, that would significantly affect the absorption of AZD2171, including the ability to swallow the tablet whole
9) Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 in the presence or absence of a stable regimen of hypertensive therapy. Measurements will be made after the subject has been resting supine for a minimum of 5 minutes. Two or more reading should be taken at 2-minute intervals and average. If the first diastolic readings differ by more than 5mmHg, then an additional reading should be obtained and averaged.
10) Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac including clinically significant arrhythmias, hepatic or renal disease)
11) Mean QTc with Bazetts correction >470msec in screening ECG or history of familial long QT syndrome. ( as per FDA guideline E14)
12) Recent(<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed
13) Treatment with an investigational drug within 30 days prior to the first dose of AZD2171.
14) Broncho alveolar carcinoma
15) Diabetes patients with type I insulin dependent diabetes or poorly controlled type II insulin dependant diabetes or a fasting blood glucose >10mmol/l as FDG-PET scanning is contra indicated in such patients. Patients with diabetes may or may not be well controlled and the presence of altered insulin or glucose levels can interfere with PET scanning and may result in a false negative test
16) Known hypersensitivity to AZD2171 or any of it's excipients
17) Any concurrent condition or laboratory finding which, in the investigator's opinion, makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol
18) Known infection with hepatitis B or C or HIV
19) Pregnant or breast feeding patients or patients of child bearing potential with a positive pregnancy test prior to receiving study medication
20) Significant haemorrhage (>30 mL/episode in the previous 3 months) or haemoptysis (>5mL in previous 4 weeks)
21) Presence of necrotic/haemorrhagic tumour or metastases
22) Concomitant anticoagulant therapy, except for administration of low-dose anticoagulants for maintenance of central venous access.
23) Unresolved toxicity >CTC grade 2 from previous anti-cancer therapy except alopecia
24) Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff as the study site)
25) Previous enrolment or randomisation of treatment in the present study.
26) Other concomitant anti-cancer therapy (including LHRH agonists) except steriods |