Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165503

Purpose

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 effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.

Condition	Intervention	Phase
Pleural Mesothelioma Malignant Pleural Mesothelioma	Drug: Cisplatin Drug: Sodium Thiosulfate Drug: ALIMTA	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma Surgery

Drug Information available for: Sodium thiosulfate Cisplatin Pemetrexed Pemetrexed disodium Sodium hyposulfite

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients undergoing surgery with hyperthermic cisplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the morbidity and mortality of this treatment protocol [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
to determine time to tumor recurrence and patient survival [ Time Frame: TBD ] [ Designated as safety issue: No ]
to evaluate the pharmacokinetics of intraoperatively administered cisplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Heated cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery. Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles.

Given intravenously over 6 hours following heated cisplatin lavage.

Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165503

Contacts

Contact: David J. Sugarbaker, MD

617-732-5004

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: David J. Sugarbaker, MD
Dana-Farber Cancer Institute	Active, not recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

David J. Sugarbaker, MD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( David Sugarbaker, MD )
Study ID Numbers:	04-063
Study First Received:	September 12, 2005
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00165503 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

pleurectomy
decortication
cisplatin
ALIMTA

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Antioxidants
Sodium thiosulfate
Adjuvants, Immunologic
Folate
Folinic Acid
Folic Acid Antagonists
Vitamin B9
Folic Acid

Pemetrexed
Anti-Bacterial Agents
Cisplatin
Radiation-Sensitizing Agents
Mesothelioma
Antitubercular Agents
Chelating Agents
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antioxidants
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Mesothelial
Physiological Effects of Drugs
Anti-Bacterial Agents
Cisplatin
Therapeutic Uses
Antidotes
Neoplasms by Histologic Type

Sodium thiosulfate
Enzyme Inhibitors
Folic Acid Antagonists
Protective Agents
Pharmacologic Actions
Pemetrexed
Neoplasms
Radiation-Sensitizing Agents
Mesothelioma
Antitubercular Agents
Chelating Agents
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 09, 2009