An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma

A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.

A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.

Inclusion Criteria:

• Diagnosed with mesothelioma
• Previously treated with only one course of chemotherapy for mesothelioma
• No previous treatment with vinorelbine
• No serious heart problems within the last 3 months

Exclusion Criteria:

• Serious abnormal laboratory values
• Severe or uncontrolled disease or condition as judged by the Investigator
• Pregnant or breast-feeding women
• Other cancers within the last 5 years
• Major surgery or radiation therapy within 4 weeks prior to starting study therapy
• Receipt of any investigational agents within 30 days prior to commencing study treatment.