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Phase II Study of Neoadjuvant Chemotherapy Comprising Pemetrexed Disodium and Cisplatin Followed By Extrapleural Pneumonectomy and High-Dose Postoperative 3D-Conformal Radiotherapy in Patients With Malignant Pleural Mesothelioma

 

Alternate Title

Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

Basic Trial Information

Phase: Phase II
Type: Treatment
Status: Active
Age: Under 70
Sponsor: Other
Protocol IDs: EORTC-08031, EudraCT-2004-004273-28, NCT00227630

Objectives

Primary

1. 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

1. Determine the toxicity of this regimen in these patients.
2. Determine progression-free survival and overall survival of patients treated with this regimen.

Entry 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


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])

Patient Characteristics:

Age:
  • Under 70
Performance status
  • WHO 0-1
Life expectancy
  • Not specified
Hematopoietic
  • WBC > 3,500/mm3
  • Absolute neutrophil count > 1,500/mm3
  • Platelet count > 100,000/mm3
  • 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
 

Projected Accrual

A total of 52 patients will be accrued for this study.

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Paul Van Schil, MD, Protocol chair
Ph: 32-30-821-37-69
Email: paul.van.schil@uza.be

Trial Sites and Contacts

Edegem, Belgium

Universitair Ziekenhuis Antwerpen
Paul Van Schil, MD
Ph: 32-30-821-37-69
Email: paul.van.schil@uza.be


  

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