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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Mesothelioma

Intervention / Treatment
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* Drug: Vinorelbine
* Drug: Vandetanib


Participation Criteria
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Eligibility Criteria
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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.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Vinorelbine | Drug: Vinorelbine<br> <br> * Other names: Navelbine®;|
| Experimental: 2<br>Vandetanib | Drug: Vandetanib<br>* once daily oral dose<br>* Other names: ZACTIMA™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Disease Control. | Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD. | Assessed at 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Objective Response. | Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. | Assessed at 2 months. | 
| Progression-free Survival (PFS) | Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. | Assessed from baseline to 12 months. | 
| Overall Survival (OS) |  | Assessed from baseline to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesothelioma, inoperable, relapsed