A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin
18 Years
N/A
Both
Pleural Mesothelioma, Malignant Pleural Mesothelioma
Trial Information
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
surgery.
- 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.
Inclusion Criteria:
- Histopathologic confirmation of malignant pleural mesothelioma
- Patients who are able to tolerate surgical cytoreduction but unable to undergo
extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion or
those with minimal disease
- Male on non-pregnant female
- 18 years of age or older
- No evidence of spread outside the ipsilateral hemithorax by chest CT and chest MRI
- Ejection fraction > 45%
- Pre-operative WBC > 4K/uL
- Estimated life expectancy of at least 12 weeks
- Evidence of adequate renal and hepatic function
- Grossly normal contralateral pulmonary function with a chest radiograph and chest CT
scan
- Karnofsky performance status of 70% or greater
- No evidence of disease progression by chest CT or chest MRI, obtained at 8 weeks
following surgery
Exclusion Criteria:
- Extended disease outside the ipsilateral hemithorax as determined on pre-operative
radiographs or intraoperative findings
- Positive extrapleural nodes as determined by mediastinoscopy
- Gross disease (estimated thickness > 10mm at any intrathoracic location) present
within the hemithorax after surgery
- Evidence of distant metastatic disease
- Severe non-malignant co-morbid disease, uncontrolled angina, myocardial infarction on
the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
- Pregnant or breast-feeding
- Serious concomitant systemic disorders
- Presence of active concomitant malignancy
- Psychiatric or addictive disorders, which would preclude informed consent
- Previous chemotherapy or radiation therapy for mesothelioma
- Chemotherapy or radiation therapy administered within 3 years for another malignancy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients undergoing surgery with hyperthermic cisplatin.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
David J. Sugarbaker, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brigham and Women's Hospital
Authority:
United States: Institutional Review Board
Study ID:
04-063
NCT ID:
NCT00165503
Start Date:
April 2004
Completion Date:
December 2010
Related Keywords:
- Pleural Mesothelioma
- Malignant Pleural Mesothelioma
- pleurectomy
- decortication
- cisplatin
- ALIMTA
- Mesothelioma
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
