Full Text View
Tabular View
No Study Results Posted
Related Studies
Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2009
First Received: April 9, 2007   Last Updated: April 22, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00458913
  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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
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 National Cancer Institute (NCI):

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 ]

Estimated Enrollment: 76
Study Start Date: February 2007
Estimated Primary Completion Date: December 2009 (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, England
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person     44-20-8642-6011        
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Mary O'Brien, MD Royal Marsden - Surrey
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000538677, EORTC-08052, JJPRD-26866138CAN2012, EUDRACT-2006-000009-51
Study First Received: April 9, 2007
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00458913     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
recurrent malignant mesothelioma
advanced malignant mesothelioma

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

ClinicalTrials.gov processed this record on November 27, 2009