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| ID | Type | Description | Link |
|---|---|---|---|
| LILLY-H3E-US-JMGS |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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 recurrent cancer of the cervix.
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 22-60 patients will be accrued for this study within 1-2 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 carcinoma of the cervix
Measurable disease
Not amenable to surgery, radiotherapy, or other therapy
Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or non-squamous cell carcinoma of the cervix
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
At least 24 hours since prior growth factors
One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
No concurrent routine colony-stimulating factors
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 3 weeks since other prior therapy for the malignant tumor
No nonsteroidal anti-inflammatory drugs for 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 |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18455781 | Result | Miller DS, Blessing JA, Bodurka DC, Bonebrake AJ, Schorge JO; Gynecologic Oncology Group. Evaluation of pemetrexed (Alimta, LY231514) as second line chemotherapy in persistent or recurrent carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2008 Jul;110(1):65-70. doi: 10.1016/j.ygyno.2008.03.009. Epub 2008 May 5. |
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| Doctors Medical Center |
| Modesto |
| California |
| 95350-4138 |
| United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | 60521 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Women's Cancer Center - Las Vegas | Las Vegas | Nevada | 89102 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Hope A Women's Cancer Center | Asheville | North Carolina | 28801 | 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 | United States |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Williamette Gynecologic Oncology P.C. | Salem | Oregon | 97301 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298-0037 | United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| 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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