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Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458913
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : July 12, 2018
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with cisplatin works as first-line therapy in treating patients with malignant mesothelioma.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: bortezomib Drug: cisplatin Phase 2

Detailed Description:


  • Determine the activity and safety of bortezomib and cisplatin as first-line treatment in patients with malignant mesothelioma.
  • Validate the use of progression-free survival rate as a primary endpoint for the design of phase II mesothelioma trials.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive cisplatin IV over 1 hour on day 1 and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma
Study Start Date : February 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Primary Outcome Measures :
  1. Progression-free survival (PFS) rate at 18 weeks

Secondary Outcome Measures :
  1. Overall objective response rate
  2. Symptomatic response rate
  3. Safety as measured by NCI CTCAE v3.0 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire
  4. Duration of PFS
  5. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed pleural malignant mesothelioma, meeting 1 of the following criteria:

    • Recurrent disease after radical surgery
    • Disease not considered suitable for radical treatment
  • Measurable or evaluable disease
  • No clinical evidence of brain or leptomeningeal metastases


  • WHO performance status 0-1
  • Life expectancy > 12 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Creatinine clearance > 60 mL/min OR > 50 mL/min
  • ALT and AST < 2.5 times upper limit of normal (ULN) (< 5 times ULN if liver metastases present)
  • Bilirubin < 1.5 times ULN
  • No concurrent secondary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
  • No other malignancy treated within the past 5 years

    • Melanoma, breast cancer, or hypernephroma treated within the past 5 years and without recurrence are allowed
  • No uncontrolled or severe cardiovascular disease, including any of the following:

    • Myocardial infarction within the past 6 months
    • New York Heart Association class III-IV heart failure
    • Uncontrolled angina
    • Clinically significant pericardial disease or cardiac amyloidosis
  • No infiltrative pulmonary or pericardial disease
  • No preexisting peripheral neuropathy
  • No known or suspected allergy or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
  • No psychological, familial, sociological, or geographical condition that would preclude protocol compliance


  • See Disease Characteristics
  • No prior systemic chemotherapy for mesothelioma
  • No other concurrent antineoplastic agents except medications that may have antineoplastic activity but are taken for other reasons (e.g., megestrol acetate, cyclooxygenase-2 inhibitors, or bisphosphonates)
  • No other concurrent experimental agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00458913

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United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Mary O'Brien, MD Royal Marsden NHS Foundation Trust
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00458913    
Other Study ID Numbers: EORTC-08052
2006-000009-51 ( EudraCT Number )
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
localized malignant mesothelioma
recurrent malignant mesothelioma
advanced malignant mesothelioma
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents