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http://www.cancer.gov/search/ViewClinicalTrials.aspx?
cdrid=339681&version=patient&protocolsearchid=1027217
Purpose: Drugs used in chemotherapy, such as
cisplatin, use different ways to stop tumor cells from dividing so
they stop growing or die. Pemetrexed disodium may stop the growth
of tumor cells by blocking the enzymes necessary for tumor cell
growth. Giving pemetrexed disodium and cisplatin before surgery may
shrink the tumor so that it can be removed during surgery. Giving
radiation therapy after surgery may kill any remaining tumor cells.
Phase II trial to study the effectiveness of neoadjuvant pemetrexed
disodium and cisplatin followed by extrapleural pneumonectomy and
radiation therapy in treating patients who have stage I, stage II,
or stage III pleural mesothelioma.
OBJECTIVES:
Primary
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Determine the feasibility of neoadjuvant chemotherapy
comprising pemetrexed disodium and cisplatin followed by
extrapleural pneumonectomy and high-dose postoperative
3D-conformal radiotherapy, in terms of 90-day progression-free
survival, in patients with malignant pleural mesothelioma.
Secondary
OUTLINE: This is a non-randomized, multicenter
study.
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Neoadjuvant chemotherapy: Patients receive pemetrexed disodium
IV over 10 minutes and cisplatin IV over 2 hours on day 1.
Treatment repeats every 3 weeks for up to 3 courses in the
absence of disease progression or unacceptable toxicity.
Patients are evaluated 3 weeks after completion of neoadjuvant
chemotherapy. Patients without disease progression proceed to
surgery.
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Extrapleural pneumonectomy: Within 21-56 days after completion
of neoadjuvant chemotherapy, patients undergo extrapleural
pneumonectomy. Patients are evaluated 30 days after surgery.
Patients without disease progression undergo high-dose
3D-conformal radiotherapy.
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High-dose 3D-conformal radiotherapy: Beginning 30-84 days after
surgery, patients undergo high-dose 3D-conformal radiotherapy
daily for 30 days.
After completion of study treatment, patients are followed on days
42 and 90, every 3 months for 1 year, and then every 6 months
thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be
accrued for this study.
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignant pleural mesothelioma
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All subtypes allowed
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T1-3, N0-1, M0 disease
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No N2 or N3 involvement confirmed by mediastinoscopy within 21
days before study entry
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No clinical invasion of mediastinal structures (e.g., heart,
aorta, spine, esophagus)
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No wide-spread chest wall invasion except focal chest wall
lesions
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No clinical or radiological evidence of shrinking hemithorax
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No clinically significant third-space fluid (e.g., pleural
effusions or ascites) that cannot be managed with thoracentesis
or pleurodesis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
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WBC > 3,500/mm^3
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Absolute neutrophil count > 1,500/mm^3
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Platelet count > 100,000/mm^3
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Hemoglobin ≥ 11 g/dL
Hepatic
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AST and ALT < 1.5 times upper limit of normal (ULN)
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Bilirubin < 1.5 times ULN
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Alkaline phosphatase < 1.5 times ULN
Renal
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Creatinine clearance ≥ 60 mL/min
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Acceptable (predicted) post-radiotherapy renal function by
semiquantitative isotope renography, with a relative
contribution of the contralateral kidney of ≥ 40%
Pulmonary
Other
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception during and
for 3 months after completion of study treatment
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Deemed to be fit enough to undergo study treatment
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No preexisting sensory neurotoxicity > grade 1
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No uncontrolled infection
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No prior or concurrent melanoma, breast cancer, or
hypernephroma
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No other malignancy within the past 5 years except carcinoma in
situ of the cervix or adequately treated basal cell skin cancer
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No psychological, familial, sociological, or geographical
condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
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No concurrent immunotherapy
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No concurrent routine use of colony-stimulating factors during
neoadjuvant chemotherapy
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Concurrent secondary prophylactic use allowed during
neoadjuvant chemotherapy
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No concurrent secondary prophylactic use of colony-stimulating
factors during post-operative radiotherapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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No other concurrent anticancer therapy
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No other concurrent experimental medications
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No nonsteroidal anti-inflammatory drugs or salicylates for 2
days before, during, and 2 days after administration of
neoadjuvant chemotherapy (5 days before and 2 days after for
drugs with a long half-life [e.g., naproxen, piroxicam,
diflunisal, or nabumetone])
Treatment/Intervention:
Patients will receive an infusion of pemetrexed disodium and a
1-hour infusion of cisplatin every 3 weeks for up to four courses.
Within 3-8 weeks after completing chemotherapy, patients will
undergo surgery. Beginning 4-8 weeks after surgery, they will
undergo radiation therapy to the chest 5 days a week for up to 6
weeks. Patients will be evaluated every 3 months for 2 years.
Important:
If you are interested in participating in a clinical trial, contact
your doctor for a referral or call a trial contact person listed
below. If you have questions about cancer or clinical trials, call
the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
General information about clinical trials, including risks,
benefits, and costs, can be found on NCI's Web site.
Trial Sites and Contacts
Please refer to this study by ClinicalTrials.gov identifier
NCT00227630
Belgium
Universitair Ziekenhuis Antwerpen, Edegem, B-2650, Belgium;
Recruiting
Paul Van Schil, MD 32-30-821-37-69
paul.van.schil@uza.be
Study chairs or principal investigators
Paul Van Schil, MD, Study Chair, Universitair Ziekenhuis Antwerpen
*** POSTED OCTOBER 2003 ***
*** RE-POSTED SEPTEMBER 2005 ***
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