Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
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ClinicalTrials.gov Identifier: NCT00227630 |
Recruitment Status :
Completed
First Posted : September 28, 2005
Last Update Posted : July 18, 2012
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RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Mesothelioma | Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy | Phase 2 |
OBJECTIVES:
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | Non-Randomized |
Primary Purpose: | Treatment |
Official Title: | A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | August 2007 |

- Feasibility in terms of 90-day progression-free survival
- Toxicity
- Progression-free survival
- Overall survival

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Ages Eligible for Study: | up to 69 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
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])

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227630
Belgium | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Italy | |
Istituto Nazionale per la Ricerca sul Cancro | |
Genoa, Italy, 16132 | |
Azienda Ospedaliera Di Parma | |
Parma, Italy, 43100 | |
Universita Degli Studi di Udine | |
Udine, Italy, 33100 | |
Netherlands | |
Sint Antonius Ziekenhuis | |
Nieuwegein, Netherlands, 3435 CM | |
Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
Rotterdam, Netherlands, 3008 AE | |
United Kingdom | |
Princess Royal Hospital at Hull and East Yorkshire NHS Trust | |
Hull, England, United Kingdom, HU8 9HE | |
Edinburgh Cancer Centre at Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 2XU |
Study Chair: | Paul Van Schil, MD, PhD | University Hospital, Antwerp |
Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
ClinicalTrials.gov Identifier: | NCT00227630 |
Other Study ID Numbers: |
EORTC-08031 EORTC-08031 2004-004273-28 ( EudraCT Number ) |
First Posted: | September 28, 2005 Key Record Dates |
Last Update Posted: | July 18, 2012 |
Last Verified: | July 2012 |
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