Bortezomib and Cisplatin as First-Line Therapy in Treating Patients With Malignant Mesothelioma
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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 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma |
- Progression-free survival (PFS) rate at 18 weeks [ Designated as safety issue: No ]
- Overall objective response rate [ Designated as safety issue: No ]
- Symptomatic response rate [ Designated as safety issue: No ]
- Safety as measured by NCI CTCAE v3.0 and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity questionnaire [ Designated as safety issue: Yes ]
- Duration of PFS [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | February 2007 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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 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.
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:
- 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
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
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00458913 History of Changes |
| Other Study ID Numbers: | EORTC-08052, JJPRD-26866138CAN2012, 2006-000009-51 |
| Study First Received: | April 9, 2007 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
localized malignant mesothelioma recurrent malignant mesothelioma advanced malignant mesothelioma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013