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Treating Patients With Malignant Mesothelioma Clinical Study Is Currently Recruiting Patients
By National Cancer Institute (NCI)
July 29, 2005
This study is currently recruiting patients.
Sponsors and Collaborators: University of Chicago Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known if combination chemotherapy works better with or without bevacizumab in treating malignant mesothelioma.
PURPOSE: This randomized phase II trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have malignant mesothelioma.
Condition Intervention Phase
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
Drug: bevacizumab
Drug: cisplatin
Drug: gemcitabine
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: antibody therapy
Procedure: biological response modifier therapy
Procedure: chemotherapy
Procedure: growth factor antagonist therapy
Procedure: monoclonal antibody therapy
Phase II
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Mesothelioma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Gemcitabine and Cisplatin with Or Without Bevacizumab in Patients with Malignant Mesothelioma
Further Study Details:
OBJECTIVES:
Compare the time to progression of patients with malignant mesothelioma treated with gemcitabine and cisplatin with or without bevacizumab.
Compare the objective response rate in patients treated with these regimens.
Compare the toxicity of these regimens when administered to these patients.
Compare the median and overall survival of patients treated with these regimens.
Assess plasma vascular endothelial growth factor and serum vascular cell adhesion molecule-1 levels before, during, and after study therapy as predictors of outcome in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to histology (epithelial vs other) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms.
Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes (beginning after gemcitabine infusion) and bevacizumab IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), complete response (CR), or partial response (PR) after the sixth course may receive bevacizumab as a single agent once every 3 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine and cisplatin as in arm I and placebo IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats as in arm I. Patients who achieve SD, CR, or PR after the sixth course may receive placebo as a single agent once every 3 weeks in the absence of disease progression.
PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 16 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma that is not amenable to curative surgery
Epithelial, sarcomatoid, or mixed subtype
Evidence of gross unresectability, including, but not limited to, the following conditions:
Direct extension into the chest wall
Mediastinal or hilar lymphadenopathy
Pulmonary or cardiac function that is inadequate to tolerate resection
Sarcomatoid or mixed histology
Pleural mesothelioma must be stage II or greater using the International Mesothelioma Interest Group staging system
Measurable disease outside prior irradiation port
At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Pleural effusions and ascites are not considered measurable lesions
Site in pleura, lung, liver, or retroperitoneum that can be assessed by MRI for evaluation of blood flow
No obvious tumor involvement of major vessels by CT scan
No known brain metastases
PATIENT CHARACTERISTICS: Age:
18 and over
Performance status:
ECOG 0-1
Life expectancy:
More than 3 months
Hematopoietic:
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No history of bleeding diathesis
Hepatic:
Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal
INR no greater than 1.5
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
If 1+ or greater proteinuria on dipstick, then must have less than 500 mg of protein/24-hour urine collection
No significant renal impairment
Cardiovascular:
See Disease Characteristics
No history deep vein thrombosis
No myocardial ischemia or infarction within the past 6 months
No uncompensated coronary artery disease within the past 6 months
No uncontrolled hypertension
No symptomatic congestive heart failure
No unstable angina pectoris within the past 6 months
No cardiac arrhythmia
No transient ischemic attack within the past 6 months
No cerebrovascular accident within the past 6 months
No other arterial thromboembolic event within the past 6 months
No clinically significant peripheral artery disease
Pulmonary:
See Disease Characteristics
No history of pulmonary embolism
Other:
No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other study agents
No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No ongoing or active infection
No other concurrent uncontrolled illness that would preclude study participation
No psychiatric illness or social situations that would preclude compliance
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy:
No growth factors for 24 hours before, during, or for 24 hours after cytotoxic chemotherapy
Chemotherapy:
See Biologic therapy
Prior intrapleural cytotoxic agents (including bleomycin) allowed
No prior systemic cytotoxic chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
Surgery:
See Disease Characteristics
At least 6 weeks since prior major surgery
Other:
At least 30 days since prior investigational drug
No other concurrent investigational or commercial agents or therapies
No concurrent combination antiretroviral therapy for HIV-positive patients
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00027703
California
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
City of Hope Medical Group, Pasadena, California, 91105, United States; Recruiting
Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
David R. Gandara, MD 916-734-3772 david.gandara@ucdmc.ucdavis.edu
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033-0804, United States; Recruiting
David I. Quinn, MD 323-865-0456 diquinn@hsc.usc.edu
Florida
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Elizabeth A. Johnson, MD 904-953-7080 johnson.elizabeth2@mayo.edu
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153, United States; Recruiting
Joseph I. Clark, MD 708-327-3236 jclark@lumc.edu
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Hedy L. Kindler, MD 773-702-0360
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
David A. Taber, MD 574-647-3353
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-1000, United States; Recruiting
Julie Brahmer, MD 410-502-7159
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Pasi Janne, MD, PhD 617-632-6076 pjanne@partners.org
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States; Recruiting
Panos Fidias, MD 617-726-9298 pfidias2@partners.org
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Shirish M. Gadgeel, MD 313-745-8389 gadgeels@karmanos.org
Minnesota
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Randolph S. Marks, MD 507-284-2511
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Lee M. Krug, MD 212-639-8420
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104-4283, United States; Recruiting
Tracey Evans, MD 215-662-6681
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15232, United States; Recruiting
Chandra Prakash Belani, MD 412-648-6619 belanicp@upmc.edu
Texas
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, 77230-1402, United States; Recruiting
Charles Lu, MD 713-792-6363 clu@mdanderson.org
Wisconsin
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226, United States; Recruiting
Stuart J. Wong, MD 414-805-4603
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792, United States; Recruiting
Anne Traynor, MD 608-263-5389
Study chairs or principal investigators
Hedy L. Kindler, MD, Study Chair, University of Chicago Cancer Research Center
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