Sorafenib in Treating Patients with Malignant Mesothelioma

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.

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 ¡Ý 20 mm by conventional techniques OR ¡Ý 10 mm by spiral CT scan

  • Target lesion must be outside prior radiotherapy port

  • Patients with pleural rind only disease must have ¡Ý 1 level with 1 rind measuring ¡Ý 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 ¡Ý 1,500/mm^3

  • Platelet count ¡Ý 100,000/mm^3

  • No bleeding diathesis

Hepatic

  • Bilirubin ¡Ü 1.5 times upper limit of normal (ULN)

  • AST ¡Ü 2.5 ULN

  • INR < 1.5

Renal

  • Creatinine ¡Ü 1.5 times ULN OR

  • Creatinine clearance ¡Ý 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

Graham 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

*** POSTED JULY 28, 2005 ***