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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00101283 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma.
PURPOSE: This randomized phase II trial is studying pemetrexed disodium and gemcitabine to see how well they work compared to pemetrexed disodium and carboplatin in treating patients with advanced malignant pleural mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial |
| Estimated Enrollment: | 32 |
| Study Start Date: | November 2005 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1.
|
Drug: carboplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: pemetrexed disodium
Given IV
|
|
Arm II: Experimental
Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
|
Drug: carboplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: pemetrexed disodium
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion of chemotherapy, all patients receive oral folic acid once daily and cyanocobalamin (vitamin B12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32-60 patients (16-30 per treatment arm) will be accrued for this study within 12.8-27.0 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
Prior radiotherapy to the target lesion allowed provided both of the following criteria are met:
Surgery
Other
Contacts and Locations
Show 120 Study Locations| Study Chair: | Nasser H. Hanna, MD | Indiana University Melvin and Bren Simon Cancer Center |
| Investigator: | Corey J. Langer, MD | Fox Chase Cancer Center |
| Study Chair: | Scott Okuno, MD | Mayo Clinic |
More Information
| Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
| Study ID Numbers: | CDR0000401795, ECOG-E1B03, NCCTG-E1B03 |
| Study First Received: | January 7, 2005 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00101283 History of Changes |
| Health Authority: | United States: Federal Government |
|
advanced malignant mesothelioma recurrent malignant mesothelioma |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Mesothelial Physiological Effects of Drugs Enzyme Inhibitors Carboplatin Folic Acid Antagonists |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Pemetrexed Neoplasms Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Gemcitabine Adenoma Neoplasms, Glandular and Epithelial |