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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060190 |
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with gemcitabine works in treating patients with pleural or peritoneal malignant mesothelioma.
Condition | Intervention | Phase |
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Malignant Mesothelioma |
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial |
Study Start Date: | February 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and pemetrexed disodium IV over 8-15 minutes on day 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months.
PROJECTED ACCRUAL: A total of 18-73 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural or peritoneal mesothelioma of 1 of the following subtypes:
Measurable disease
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 days of pemetrexed disodium administration
United States, Ohio | |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000299535, CWRU-LILY-1502, LILLY-H3E-US-JMFZ(b) |
Study First Received: | May 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00060190 History of Changes |
Health Authority: | United States: Federal Government |
advanced malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma |
Folic Acid Antimetabolites Pemetrexed Radiation-Sensitizing Agents Immunologic Factors Mesothelioma |
Folic Acid Antagonists Gemcitabine Immunosuppressive Agents Antiviral Agents Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Pemetrexed Neoplasms Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Gemcitabine Adenoma Neoplasms, Glandular and Epithelial |