Mesothelioma Clinical Trials
Pemetrexed Disodium and Cisplatin Followed by Surgery and
Radiation Therapy in Treating Patients With Pleural
This study is currently
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
|localized malignant mesothelioma
| Drug: cisplatin
Procedure: enzyme inhibitor
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
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