Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer
NCT ID: NCT00087100
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with persistent or recurrent endometrial cancer.
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Detailed Description
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* Determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma that failed higher priority treatment protocols.
* Determine the nature and degree of toxicity of this drug in these patients.
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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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pemetrexed disodium
Eligibility Criteria
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Inclusion Criteria
Age
* Any age
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* AST and ALT ≤ 3 times upper limit of normal (ULN)\*
* Alkaline phosphatase ≤ 3 times ULN\*
* Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 5 times ULN if liver metastases are present
Renal
* Creatinine clearance ≥ 45 mL/min
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
* Neuropathy (sensory and motor) ≤ grade 1
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
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:
* Monoclonal antibodies
* Cytokines
* Small-molecule inhibitors of signal transduction
* At least 24 hours since prior growth factors
* No concurrent routine colony-stimulating factors
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy
* No prior pemetrexed disodium
Endocrine therapy
* At least 1 week since prior hormonal therapy directed at the malignant tumor
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy and recovered
* No prior radiotherapy to ≥ 25% of bone marrow
Surgery
* Recovered from prior 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
* Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed
* No prior therapy that would contraindicate study participation
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David S. Miller, MD
Role: STUDY_CHAIR
Simmons Cancer Center
Locations
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Countries
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References
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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.
Other Identifiers
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LILLY-H3E-US-JMGT
Identifier Type: -
Identifier Source: secondary_id
CDR0000372921
Identifier Type: -
Identifier Source: secondary_id
GOG-0129O
Identifier Type: -
Identifier Source: org_study_id
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