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 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

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 periodically.

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		2009-04-21

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