Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
NCT ID: NCT00227630
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma.
Detailed Description
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Primary
* 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
* Determine the toxicity of this regimen in these patients.
* Determine progression-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, multicenter study.
* 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.
* 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.
* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
Interventions
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cisplatin
pemetrexed disodium
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed malignant pleural mesothelioma
* All subtypes allowed
* T1-3, N0-1, M0 disease
* No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study entry
* No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus)
* No wide-spread chest wall invasion except focal chest wall lesions
* No clinical or radiological evidence of shrinking hemithorax
* No clinically significant third-space fluid (e.g., pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis
PATIENT CHARACTERISTICS:
Age
* Under 70
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC \> 3,500/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin ≥ 11 g/dL
Hepatic
* AST and ALT \< 1.5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Alkaline phosphatase \< 1.5 times ULN
Renal
* Creatinine clearance ≥ 60 mL/min
* Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥ 40%
Pulmonary
* See Disease Characteristics
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Deemed to be fit enough to undergo study treatment
* No preexisting sensory neurotoxicity \> grade 1
* No uncontrolled infection
* No prior or concurrent melanoma, breast cancer, or hypernephroma
* No other malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
* No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy
* Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy
* No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy
Chemotherapy
* No prior chemotherapy for mesothelioma
Endocrine therapy
* No concurrent hormonal cancer therapy
Radiotherapy
* No prior radiotherapy to the lower neck, thorax, or upper abdomen
Surgery
* See Disease Characteristics
Other
* No other concurrent anticancer therapy
* No other concurrent experimental medications
* 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 \[e.g., naproxen, piroxicam, diflunisal, or nabumetone\])
69 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Paul Van Schil, MD, PhD
Role: STUDY_CHAIR
University Hospital, Antwerp
Locations
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Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Istituto Nazionale per la Ricerca sul Cancro
Genoa, , Italy
Azienda Ospedaliera Di Parma
Parma, , Italy
Universita Degli Studi di Udine
Udine, , Italy
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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O'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16.
Van Schil PE, Baas P, Gaafar R, Maat AP, Van de Pol M, Hasan B, Klomp HM, Abdelrahman AM, Welch J, van Meerbeeck JP; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group. Trimodality therapy for malignant pleural mesothelioma: results from an EORTC phase II multicentre trial. Eur Respir J. 2010 Dec;36(6):1362-9. doi: 10.1183/09031936.00039510. Epub 2010 Jun 4.
Other Identifiers
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EORTC-08031
Identifier Type: -
Identifier Source: secondary_id
2004-004273-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EORTC-08031
Identifier Type: -
Identifier Source: org_study_id