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Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma


- 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.

Inclusion Criteria


- Histologically confirmed pleural malignant mesothelioma, meeting 1 of the following

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate at 18 weeks

Safety Issue:


Principal Investigator

Mary O'Brien, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United States: Federal Government

Study ID:




Start Date:

February 2007

Completion Date:

March 2012

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • recurrent malignant mesothelioma
  • advanced malignant mesothelioma
  • Mesothelioma