Mesothelioma Related Clinical Trials:
Phase II Study of Bortezomib (VELCADE) With Cisplatin as First Line Treatment of Malignant Mesothelioma
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Status: Recruiting
Sponsors and Collaborators: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00458913
Condition: Malignant Mesothelioma
Intervention: Drug: bortezomib; Drug: cisplatin; Procedure: antiangiogenesis therapy; Procedure: chemotherapy; Procedure: enzyme inhibitor therapy
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.
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| 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 ]
| Estimated Enrollment: | 76 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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 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 every 3 months.
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 |
Criteria
DISEASE CHARACTERISTICS:
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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 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:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458913Locations
| United Kingdom, England | |||||
| Royal Marsden NHS Foundation Trust - Surrey | Recruiting | ||||
| Sutton, England, United Kingdom, SM2 5PT | |||||
| Contact: Contact Person 44-20-8642-6011 | |||||
Sponsors and Collaborators
| European Organization for Research and Treatment of Cancer |
Investigators
| Study Chair: | Mary O'Brien, MD | Royal Marsden NHS Foundation Trust |
Additional Information:
| Study ID Numbers: Â | CDR0000538677, EORTC-08052, JJPRD-26866138CAN2012, EUDRACT-2006-000009-51 |
| First Received: Â | April 9, 2007 |
| Last Updated: Â | December 25, 2007 |
| ClinicalTrials.gov Identifier: Â | NCT00458913 |
| Health Authority: Â | Unspecified |
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