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Mesothelioma Clinical Trials

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma

This study is currently recruiting patients.

Sponsored by

University of Chicago Cancer Research Center
For more information:National Cancer Institute (NCI)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without bevacizumab in treating malignant mesothelioma.

PURPOSE: Randomizedphase II trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have malignant mesothelioma.

Condition Treatment or Intervention
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
 Drug: bevacizumab
 Drug: cisplatin
 Drug: gemcitabine
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: growth factor antagonist therapy
 Procedure: monoclonal antibody therapy

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.  

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Gemcitabine and Cisplatin With or Without Bevacizumab in Patients With Malignant Mesothelioma

Further Study Details: 


  • Compare the time to progression of patients with malignant mesothelioma treated with gemcitabine and cisplatin with or without bevacizumab.
  • Compare the objective response rate in patients treated with these regimens.
  • Compare the toxicity of these regimens when administered to these patients.
  • Compare the median and overall survival of patients treated with these regimens.
  • Assess plasma vascular endothelial growth factor and serum vascular cell adhesion molecule-1 levels before, during, and after study therapy as predictors of outcome in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to histology (epithelial vs other) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes (beginning after gemcitabine infusion) and bevacizumab IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), complete response (CR), or partial response (PR) after the sixth course may receive bevacizumab as a single agent once every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine and cisplatin as in arm I and placebo IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats as in arm I. Patients who achieve SD, CR, or PR after the sixth course may receive placebo as a single agent once every 3 weeks in the absence of disease progression.

PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 16 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma that is not amenable to curative surgery
  • Epithelial, sarcomatoid, or mixed subtype
  • Evidence of gross unresectability, including, but not limited to, the following conditions:
  • Direct extension into the chest wall
  • Mediastinal or hilar lymphadenopathy
  • Pulmonary or cardiac function that is inadequate to tolerate resection
  • Sarcomatoid or mixed histology
  • Pleural mesothelioma must be stage II or greater using the International Mesothelioma Interest Group staging system
  • Measurable disease outside prior irradiation port
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Pleural effusions and ascites are not considered measurable lesions
  • Site in pleura, lung, liver, or retroperitoneum that can be assessed by MRI for evaluation of blood flow
  • No obvious tumor involvement of major vessels by CT scan
  • No known brain metastases

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