A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
- 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
- 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
- Determine the pattern of relapse (local vs metastatic) in patients treated with this
- 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.
Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate
Lee M. Krug, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|