Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
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.
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.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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