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| ID | Type | Description | Link |
|---|---|---|---|
| JJPRD-26866138CAN2012 | |||
| 2006-000009-51 | EudraCT Number |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug | |||
| cisplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate at 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed pleural malignant mesothelioma, meeting 1 of the following criteria:
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
No uncontrolled or severe cardiovascular disease, including any of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mary O'Brien, MD | Royal Marsden NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31576173 | Derived | Walter RFH, Sydow SR, Berg E, Kollmeier J, Christoph DC, Christoph S, Eberhardt WEE, Mairinger T, Wohlschlaeger J, Schmid KW, Mairinger FD. Bortezomib sensitivity is tissue dependent and high expression of the 20S proteasome precludes good response in malignant pleural mesothelioma. Cancer Manag Res. 2019 Sep 24;11:8711-8720. doi: 10.2147/CMAR.S194337. eCollection 2019. | |
| 23791541 |
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| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Duration of PFS |
| Overall survival |
| Derived |
| O'Brien ME, Gaafar RM, Popat S, Grossi F, Price A, Talbot DC, Cufer T, Ottensmeier C, Danson S, Pallis A, Hasan B, Van Meerbeeck JP, Baas P. Phase II study of first-line bortezomib and cisplatin in malignant pleural mesothelioma and prospective validation of progression free survival rate as a primary end-point for mesothelioma clinical trials (European Organisation for Research and Treatment of Cancer 08052). Eur J Cancer. 2013 Sep;49(13):2815-22. doi: 10.1016/j.ejca.2013.05.008. Epub 2013 Jun 20. |
| D009369 |
| Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |