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

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: Vinorelbine
  • Drug: Vandetanib
    • once daily oral dose

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Vinorelbine
  • Experimental: 2
    • Vandetanib

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Disease Control.
    • Time Frame: Assessed at 2 months.
    • 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.

Secondary Measures

  • Number of Participants With Objective Response.
    • Time Frame: Assessed at 2 months.
    • 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.
  • Progression-free Survival (PFS)
    • Time Frame: Assessed from baseline to 12 months.
    • 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.
  • Overall Survival (OS)
    • Time Frame: Assessed from baseline to 12 months.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genzyme, a Sanofi Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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