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

Phase 2TerminatedNCT00597116

Genzyme, a Sanofi Company25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mesothelioma

Interventions

VinorelbineDRUG

VandetanibDRUG

once daily oral dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Research Site

Essen, Germany

Research Site

Halle-Dolau, Germany

Research Site

Hamburg, Germany

Research Site

Heidelberg, Germany

Research Site

Chur, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Assessed at 2 months.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Assessed from baseline to 12 months.

Overall Survival (OS)

Time frame: Assessed from baseline to 12 months.

Data from ClinicalTrials.gov

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