Status:
COMPLETED
Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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, ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00458913
Start Date
February 1 2007
End Date
March 1 2012
Last Update
July 12 2018
Active Locations (1)
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1
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT