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

NCT00458913 | Completed Phase 2

• 3 other identifiers: EORTC-08052JJPRD-26866138CAN20122006-000009-51
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma; recurrent malignant mesothelioma; advanced malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate at 18 weeks

Secondary Outcomes (5)

• 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

Interventions

bortezomib DRUG

cisplatin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31576173 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.

  PMID: 23791541 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Bortezomib; Cisplatin

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds

Study Officials

• Mary O'Brien, MD

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2012
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

GB (1)