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| 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 |
| MedlinePlus related topics: | Cancer Mesothelioma |
| ChemIDplus related topics: | Cisplatin Pemetrexed disodium Pemetrexed Sodium thiosulfate Sodium hyposulfite |
| 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 or Without Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin |
| Estimated Enrollment: | 55 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Heated cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surger.
Cisplatin will also be administerd 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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |||||
| Brigham and Women's Hospital | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Dana-Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Dana-Farber Cancer Institute |
| Brigham and Women's Hospital |
| Principal Investigator: | David J. Sugarbaker, MD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Brigham and Women's Hospital ( David Sugarbaker, MD ) |
| Study ID Numbers: | 04-063 |
| First Received: | September 12, 2005 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00165503 |
| Health Authority: | United States: Institutional Review Board |
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