Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other, Pharmaceutical / Industry EORTC-08052 JJPRD-26866138CAN2012, EUDRACT-2006-000009-51, 08052, NCT00458913

Objectives

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

Entry 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

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

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 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

Expected Enrollment

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

Outcomes

Progression-free survival (PFS) rate at 18 weeks

Overall objective response rate
Symptomatic response rate
Safety as measured by NCI CTCAE v3.0 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire
Duration of PFS
Overall survival

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 every 3 months.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Mary O'Brien, MD, Protocol chair		Ph: 44-20-8661-3276 Email: mary.o'brien@rmh.nhs.uk

United Kingdom
England
	Sutton
	Royal Marsden - Surrey
		Contact Person	Ph:  44-20-8642-6011

Registry Information
Official Title		Phase II Study of Bortezomib (VELCADE) with Cisplatin as First Line Treatment of Malignant Mesothelioma
Trial Start Date		2007-02-13
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00458913
Date Submitted to PDQ		2007-03-06
Information Last Verified		2007-04-02

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