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From CommunityDispatch.com
Recruiting Patients for Study Sorafenib in Treating Patients with Malignant Mesothelioma
By National Cancer Institute (NCI)
Jul 28, 2005, 06:57
This study is currently recruiting patients.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Purpose
RATIONALE: Sorafenib 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.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with malignant mesothelioma.
Condition Intervention Phase
advanced malignant mesothelioma
epithelial mesothelioma
recurrent malignant mesothelioma
sarcomatous mesothelioma
Drug: sorafenib
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: biological response modifier therapy
Procedure: enzyme inhibitor therapy
Procedure: growth factor antagonist therapy
Phase II
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Mesothelioma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Sorafenib in Patients with Malignant Mesothelioma
Further Study Details:
OBJECTIVES: Primary
Determine the partial response and complete response rate in patients with malignant mesothelioma treated with sorafenib.
Secondary
Determine the 3-month failure-free survival of patients treated with this drug.
Determine the median and overall survival of patients treated with this drug.
Determine the toxicity profile of this drug in these patients.
Correlate the presence of mutations in exons 11 and 15 of the B-raf gene in tumor tissue with anti-tumor activity of this drug in these patients.
Correlate the amount of phospho-ERK1/2 expression in pretreatment tumor tissue with anti-tumor activity of this drug in these patients.
Correlate baseline levels of and changes in angiogenic cytokines (vascular endothelial growth factor and platelet-derived growth factor) with anti-tumor activity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 6-8 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant mesothelioma
Epithelial, sarcomatoid, or mixed type
Any site of origin (e.g., pleura, peritoneum, pericardium, or tunica vaginalis)
Measurable disease
At least 1 unidimensionally measurable lesion - 20 mm by conventional techniques OR - 10 mm by spiral CT scan
Target lesion must be outside prior radiotherapy port
Patients with pleural rind only disease must have - 1 level with 1 rind measuring - 1.5 cm
The following are not considered measurable disease:
Bone lesions
Leptomeningeal disease
Ascites
Pleural or pericardial effusions
Lymphangitis cutis/pulmonis
Abdominal masses that are not confirmed and followed by imaging techniques
Cystic lesions
Not amenable to curative surgery
Must have tissue blocks or slides from a core surgical biopsy available
No known brain metastases
PATIENT CHARACTERISTICS: Age
18 and over
Performance status
ECOG 0-1
Life expectancy
Not specified
Hematopoietic
Granulocyte count - 1,500/mm^3
Platelet count - 100,000/mm^3
No bleeding diathesis
Hepatic
Bilirubin + 1.5 times upper limit of normal (ULN)
AST + 2.5 ULN
INR < 1.5
Renal
Creatinine + 1.5 times ULN OR
Creatinine clearance - 60 mL/min
Cardiovascular
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No hypertension
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No ongoing, active infection
No psychiatric illness or social situation that would preclude study compliance
No other active malignancy except non-melanoma skin cancer, carcinoma in situ of the cervix, or any other completely treated malignancy that has< 30% chance of relapsing
No history of allergic reactions attributed to compounds of similar chemical or biological composition to study drug
No other uncontrolled illness
PRIOR CONCURRENT THERAPY: Biologic therapy
No prior angiogenesis inhibitor therapy
No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
Chemotherapy
Prior intrapleural cytotoxic chemotherapy allowed*
No more than 1 prior pemetrexed disodium-containing chemotherapy regimen (i.e., pemetrexed disodium alone or in combination with any other agent)
At least 4 weeks since prior pemetrexed disodium-containing chemotherapy regimen
No concurrent chemotherapy NOTE: *Not considered systemic chemotherapy
Endocrine therapy
No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure
Radiotherapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy
No concurrent palliative radiotherapy
Surgery
At least 3 weeks since prior major surgery
Other
No prior signal transduction inhibitor therapy
No prior protein tyrosine kinase inhibitor therapy
Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
More than 28 days since prior and no other concurrent investigational agents
No concurrent therapeutic anticoagulation therapy with warfarin or heparin derivatives
Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) for venous or arterial access devices allowed provided that the requirements for INR are met
No concurrent combination antiretroviral therapy for HIV-positive patients
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00107432
California
El Camino Hospital, Mountain View, California, 94040, United States; Recruiting
Peter P. Yu, MD 408-524-5085
Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, 92120, United States; Recruiting
Jonathan A. Polikoff, MD 619-528-5170
Delaware
Beebe Medical Center, Lewes, Delaware, 19958, United States; Recruiting
Stephen S. Grubbs, MD 302-366-1200
CCOP - Christiana Care Health Services, Newark, Delaware, 19718, United States; Recruiting
Stephen S. Grubbs, MD 302-366-1200
St. Francis Hospital, Wilmington, Delaware, 19805, United States; Recruiting
Stephen S. Grubbs, MD 302-366-1200
Florida
Florida Hospital - Orlando, Orlando, Florida, 32803, United States; Recruiting
Lee M. Zehngebot, MD 407-898-5452
Illinois
BroMenn Regional Medical Center, Normal, Illinois, 61761, United States; Recruiting
John W. Kugler, MD 309-243-3000
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, 61554, United States; Recruiting
John W. Kugler, MD 309-243-3000
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615, United States; Recruiting
John W. Kugler, MD 309-243-3000
Community Cancer Center, Normal, Illinois, 61761, United States; Recruiting
John W. Kugler, MD 309-243-3000
Community Hospital of Ottawa, Ottawa, Illinois, 61350, United States; Recruiting
John W. Kugler, MD 309-243-3000
Eureka Hospital, Eureka, Illinois, 61530, United States; Recruiting
John W. Kugler, MD 309-243-3000
Galesburg Clinic, Galesburg, Illinois, 61401, United States; Recruiting
John W. Kugler, MD 309-243-3000
Galesburg Cottage Hospital, Galesburg, Illinois, 61401, United States; Recruiting
John W. Kugler, MD 309-243-3000
raham Hospital, Canton, Illinois, 61520, United States; Recruiting
John W. Kugler, MD 309-243-3000
Hopedale Medical Complex, Hopedale, Illinois, 61747, United States; Recruiting
John W. Kugler, MD 309-243-3000
Illinois Valley Community Hospital, Peru, Illinois, 61354, United States; Recruiting
John W. Kugler, MD 309-243-3000
InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois, 61401, United States; Recruiting
John W. Kugler, MD 309-243-3000
Kewanee Hospital, Kewanee, Illinois, 61443, United States; Recruiting
John W. Kugler, MD 309-243-3000
Mason District Hospital, Havana, Illinois, 62644, United States; Recruiting
John W. Kugler, MD 309-243-3000
McDonough District Hospital, Macomb, Illinois, 61455, United States; Recruiting
John W. Kugler, MD 309-243-3000
Memorial Hospital, Carthage, Illinois, 62321, United States; Recruiting
John W. Kugler, MD 309-243-3000
Methodist Medical Center of Illinois, Peoria, Illinois, 61603, United States; Recruiting
John W. Kugler, MD 309-243-3000
Oncology Hematology Associates of Central Illinois - Ottawa, Ottawa, Illinois, 61350, United States; Recruiting
John W. Kugler, MD 309-243-3000
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, 61615, United States; Recruiting
John W. Kugler, MD 309-243-3000
OSF St. Francis Medical Center, Peoria, Illinois, 61637, United States; Recruiting
John W. Kugler, MD 309-243-3000
Perry Memorial Hospital, Princeton, Illinois, 61356, United States; Recruiting
John W. Kugler, MD 309-243-3000
Proctor Hospital, Peoria, Illinois, 61614, United States; Recruiting
John W. Kugler, MD 309-243-3000
St. Joseph Medical Center, Bloomington, Illinois, 61701, United States; Recruiting
John W. Kugler, MD 309-243-3000
St. Margaret's Hospital, Spring Valley, Illinois, 61362, United States; Recruiting
John W. Kugler, MD 309-243-3000
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Walter M. Stadler, MD, FACP 773-702-4150
Valley Cancer Center, Spring Valley, Illinois, 61362, United States; Recruiting
John W. Kugler, MD 309-243-3000
Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46815, United States; Recruiting
Sreenivasa R. Nattam, MD 260-484-8830
Maryland
Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, 21921, United States; Recruiting
Stephen S. Grubbs, MD 302-366-1200
Minnesota
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, 55455, United States; Recruiting
Bruce A. Peterson, MD 612-624-5631
Missouri
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
Jorge C. Paradelo, MD, FACR 816-823-0555
Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, 63110, United States; Recruiting
Ramaswamy Govindan, MD 314-362-4819
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
Stephen S. Grubbs, MD 302-366-1200
New York
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, 13057, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, 12801, United States; Recruiting
Michael P. Castro, MD 518-926-6701
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Lee M. Krug, MD 212-639-8420
Oswego Hospital, Oswego, New York, 13126, United States; Recruiting
Stephen L. Graziano, MD 315-464-4353
St. Joseph's Hospital Health Center - Syracuse, Syracuse, New York, 13203, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-464-4353
North Carolina
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Jeffrey Crawford, MD 919-684-5621
Lenoir Memorial Cancer Center, Kinston, North Carolina, 28501, United States; Recruiting
Peter R. Watson, MD 252-559-2201
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233, United States; Recruiting
Richard B. Reiling 704-384-9955
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, 27534, United States; Recruiting
James N. Atkins, MD 919-580-0000
Wilson Medical Center, Wilson, North Carolina, 27893, United States; Recruiting
James N. Atkins, MD 919-580-0000
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210, United States; Recruiting
William J. Hicks, MD 614-293-4372
Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, 37660, United States; Recruiting
Malcolm (Mack) R. Mathews, MD 423-224-3150
Vermont
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, 05401, United States; Recruiting
Steven M. Grunberg, MD 802-847-3827
Mountainview Medical, Berlin, Vermont, 05602, United States; Recruiting
Steven M. Grunberg, MD 802-847-3827
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25702, United States; Recruiting
Gerrit A. Kimmey, MD 304-528-4645
Study chairs or principal investigators
Pasi Janne, MD, PhD, Study Chair, Dana-Farber Cancer Institute
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