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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072397 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Giving pemetrexed disodium and cisplatin before surgery may shrink the tumor so that it can be removed during surgery. Giving radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and radiation therapy in treating patients who have stage I, stage II, or stage III pleural mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: cisplatin Drug: pemetrexed disodium Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma |
| Estimated Enrollment: | 77 |
| Study Start Date: | July 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 77 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pleural mesothelioma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No prior surgical resection of mesothelioma
Other
No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2 days before, the day of, or 2 days after study therapy
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Lee M. Krug, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000339681, MSKCC-03078, LILLY-H3E-US-JMGA |
| Study First Received: | November 4, 2003 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072397 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized malignant mesothelioma |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Pemetrexed Neoplasms Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |