Mesothelioma Clinical Trials: Cisplatin Clinical Trial
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Sponsored by:
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European Organization for Research and Treatment of Cancer
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Information provided by:
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National Cancer Institute (NCI)
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ClinicalTrials.gov Identifier:
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NCT00227630
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Purpose
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.
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Condition
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Intervention
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Phase
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Drug: cisplatin
Drug: pemetrexed disodium
Procedure: adjuvant therapy
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: drug resistance inhibition
Procedure: enzyme inhibitor therapy
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Procedure: surgery
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Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
Further study details as provided by National Cancer Institute (NCI):
Total Enrollment: 52
Study start: July 2005
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.
- Eligibility
- Ages Eligible for Study: up to 69 Years,
- Genders Eligible for Study: Both
Criteria
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
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])
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