Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating 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.
Drug: pemetrexed disodium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma|
- Feasibility in terms of 90-day progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227630
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Azienda Ospedaliera Di Parma|
|Parma, Italy, 43100|
|Universita Degli Studi di Udine|
|Udine, Italy, 33100|
|Sint Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435 CM|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Princess Royal Hospital at Hull and East Yorkshire NHS Trust|
|Hull, England, United Kingdom, HU8 9HE|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Paul Van Schil, MD, PhD||Universitair Ziekenhuis Antwerpen|