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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Non-Small-Cell Lung Carcinoma

Carcinoma

Head and Neck Neoplasms

Treatments

Drug: AZD2171

Study type

Interventional

Funder types

Industry

Identifiers

NCT00243347

D8480C00015

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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