Status:
TERMINATED
Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Pleural Mesothelioma
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effe...
Detailed Description
OBJECTIVES: Primary * To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin. Secondary * To determine the morbidit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00165503
Start Date
April 1 2004
End Date
July 1 2010
Last Update
September 9 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115