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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00458913 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: bortezomib Drug: cisplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma |
| Estimated Enrollment: | 76 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pleural malignant mesothelioma, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No other malignancy treated within the past 5 years
No uncontrolled or severe cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United Kingdom | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Study Chair: | Mary O'Brien, MD | Royal Marsden NHS Foundation Trust |
More Information
| ClinicalTrials.gov Identifier: | NCT00458913 History of Changes |
| Other Study ID Numbers: | CDR0000538677, EORTC-08052, JJPRD-26866138CAN2012, EUDRACT-2006-000009-51 |
| Study First Received: | April 9, 2007 |
| Last Updated: | June 11, 2010 |
| Health Authority: | United States: Federal Government |
|
localized malignant mesothelioma recurrent malignant mesothelioma advanced malignant mesothelioma |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Bortezomib Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |