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Mesothelioma Clinical Trials

Neoadjuvant Pemetrexed Disodium and Cisplatin Followed by Surgery and Radiation Therapy in Treating Patients With Pleural Mesothelioma

This study is currently recruiting patients.

Sponsored by

Memorial Sloan-Kettering Cancer Center
For more information:National Cancer Institute (NCI)

RATIONALE: 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.

PURPOSE: 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 IIIpleuralmesothelioma.

Condition Treatment or Intervention
localized malignant mesothelioma  Drug: cisplatin
 Drug: pemetrexed disodium
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: enzyme inhibitor therapy
 Procedure: neoadjuvant therapy
 Procedure: radiation therapy
 Procedure: surgery

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.  

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Neoadjuvant Pemetrexed Disodium and Cisplatin Followed By Extrapleural Pneumonectomy and Radiotherapy in Patients With Stage I, II, or III Pleural Mesothelioma

Further Study Details: 


  • Determine the pathological complete response rate in patients with stage I, II, or III pleural mesothelioma treated with neoadjuvant pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and radiotherapy.


  • Determine the 1- and 2-year disease-free and median survival of patients treated with this regimen.
  • Determine the clinical response rate by radiological assessment in patients treated with this regimen.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.
  • Determine the pattern of relapse (local vs metastatic) in patients treated with this regimen.
  • Determine the time to event efficacy variables (i.e., time to objective tumor response, time to treatment failure, time to progressive disease, and overall survival) in patients treated with this regimen.
  • Correlate response to treatment with this regimen with levels of TS, DHFR, GARFT, FPGS, DPD, RFCI, alpha-FR, and ERCC1 in the mesothelioma tissue of these patients.

OUTLINE: This is an open-label, multicenter study.

  • Preoperative chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Extrapleural pneumonectomy: Patients undergo extrapleural pneumonectomy within 3-8 weeks after the last course of chemotherapy.
  • Hemi-thoracic radiotherapy: Beginning 4-8 weeks after surgery, patients undergo radiotherapy to the chest once daily 5 days a week for 6 weeks. Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 77 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically confirmed pleural mesothelioma
  • Stage I, II, or III (T1-3, N0-2, M0)
  • No cardiac involvement  

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