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| ID | Type | Description | Link |
|---|---|---|---|
| LILLY-H3E-US-JMGT | |||
| CDR0000372921 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with persistent or recurrent endometrial cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 1-3.4 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed disodium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor activity | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Histologically confirmed endometrial adenocarcinoma
Refractory to curative or standard therapy
Measurable disease
Must have received 1 prior chemotherapy regimen for endometrial cancer
Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 3 weeks since prior biologic or immunologic agents for the malignant tumor
One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
At least 24 hours since prior growth factors
No concurrent routine colony-stimulating factors
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 3 weeks since other prior therapy directed at the malignant tumor
No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration
No prior therapy that would contraindicate study participation
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| Name | Affiliation | Role |
|---|---|---|
| David S. Miller, MD | Simmons Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States | ||
| Hinsdale Hematology Oncology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19804902 | Result | Miller DS, Blessing JA, Drake RD, Higgins R, McMeekin DS, Puneky LV, Krasner CN. A phase II evaluation of pemetrexed (Alimta, LY231514, IND #40061) in the treatment of recurrent or persistent endometrial carcinoma: a phase II study of the Gynecologic Oncology. Gynecol Oncol. 2009 Dec;115(3):443-6. doi: 10.1016/j.ygyno.2009.09.004. Epub 2009 Oct 4. |
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| Hinsdale |
| Illinois |
| 60521 |
| United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Alamance Cancer Center at Alamance Regional Medical Center | Burlington | North Carolina | 27216 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Lake/University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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