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http://www.clinicaltrials.gov/ct/show/NCT00027703?amp;order=1
This study is currently recruiting patients.
Sponsored by
National Cancer Institute (NCI)
University of Chicago Cancer Research Center
PURPOSE
RATIONALE: Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Monoclonal antibodies such as bevacizumab can
locate tumor cells and kill them without harming normal cells. It is not
yet known if combination chemotherapy is more effective with or without
bevacizumab in treating malignant mesothelioma .
PURPOSE: Randomized phase
II trial to compare the effectiveness of combination chemotherapy
works better with or without bevacizumab in treating patients who have malignant
mesothelioma.
Study Type: Interventional
Stuey 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:
I. Compare the time to progression of
patients with malignant mesothelioma treated with gemcitabine and
cisplatin with or without bevacizumab.
II. Compare the objective response rate
in patients treated with these regimens.
III. Compare the toxicity of these
regimens when administered to these patients.
IV. Compare the median and overall
survival of patients treated with these regimens.
V. 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.
PROTOCOL 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
Criteria
PROTOCOL ENTRY 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/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least
100,000/mm3
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 of deep vein
thrombosis
No myocardial ischemia or infarction 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
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 --
-- 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
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
dgandara@cc.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
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 Allen Taber, MD 574-237-1328
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
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 at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States; Recruiting
James Stevenson, MD 215-662-6682
Hillman Cancer Center
at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
United States; Recruiting
Chandra Prakash Belani, MD 412-648-6619
belanicp@upmc.edu
Texas
University
of Texas - MD Anderson Cancer Center
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
More
Information
Clinical trial summary
from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000069058; UCCRC-11046A; NCI-2710; NCT00027703
Record last reviewed: October
20, 2005
Record first received: December 7, 2001
ClinicalTrials.gov Identifier: NCT00027703
Health Authority: United States: Federal Government
**
FIRST POSTED MAY 3, 2002 **
** RE-POSTED JANUARY 18, 2005 **
** RE-POSTED AUGUST 8, 2005 **
** RE-POSTED NOVEMBER 0, 2005 **
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