A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin
- Patients will undergo surgery, which is part of the standard care for mesothelioma, by
a procedure called pleurectomy/decortication. This involves removal of the lining of
the lung and all visible disease. Resection of the lining of the heart and the muscle
that separates the chest and abdomen is occasionally necessary.
- Mesothelioma samples will be taken during the surgery. These samples will be used in a
laboratory study to better understand the genetic makeup of the mesothelioma and to
improve our ability to diagnose this disease.
- After the conclusion of the surgery, if a patient has less than 1cm thickness of
residual gross disease in one or more areas, then the patient will continue on this
study. If more than this volume of tumor is present, then the patient will receive
additional treatment off-study.
- Heated chemotherapy (cisplatin) will be given in the operating room immediately
following surgery. This treatment consists of a one-hour lavage of the chest and
abdominal cavity with heated cisplatin through the surgical incision. At the
completion of the hour, sodium thiosulfate is given intravenously for 6 hours to reduce
potential side effects.
- During the surgery and for four hours following the completion of the cisplatin lavage,
blood samples, urine samples, chest wall muscle samples, and samples of the
chemotherapy solution will be taken in order to measure the concentration of
chemotherapy and the impact of cisplatin in these samples.
- Patients will remain in the hospital until they have recovered from surgery (7-14
days). In addition to standard post-operative care, blood tests will be done on a
daily basis. Following discharge from the hospital, patients will be seen 1-2 weeks
post-operatively for additional blood work. An echocardiogram will be done 6 weeks and
6 months post-operatively to assess heart function.
- Chemotherapy treatment consists of ALIMTA plus cisplatin on Day 1 of every 21-day
chemotherapy cycle. A total of 3 cycles will be given starting 6-10 weeks after
- Folic acid, vitamin B12 and dexamethasone will be given in addition to the
chemotherapy to help reduce side effects of the chemotherapy drugs.
- Approximately 30 days after the last dose of ALIMTA plus cisplatin, a CT scan(s) and
blood work will be performed. In addition, patients will get a CT scan(s) every 3
months for approximately 24 months from the completion of study treatment.
- Long term follow-up will consist of clinic visits every 3 months for 2 years, every 6
months for 2 years, and then once a year.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients undergoing surgery with hyperthermic cisplatin.
David J. Sugarbaker, MD
Brigham and Women's Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|