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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00458913
First received: April 9, 2007
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Malignant Mesothelioma
Drug: bortezomib
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Progression-free survival (PFS) rate at 18 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall objective response rate [ Designated as safety issue: No ]
  • Symptomatic response rate [ Designated as safety issue: No ]
  • Safety as measured by NCI CTCAE v3.0 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire [ Designated as safety issue: Yes ]
  • Duration of PFS [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: February 2007
Study Completion Date: March 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458913

Locations
United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Mary O'Brien, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided by European Organisation for Research and Treatment of Cancer - EORTC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00458913     History of Changes
Other Study ID Numbers: EORTC-08052, JJPRD-26866138CAN2012, 2006-000009-51
Study First Received: April 9, 2007
Last Updated: April 19, 2013
Health Authority: United States: Federal Government

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:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Bortezomib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014