Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
NCT ID: NCT00087113
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
INTERVENTIONAL
2004-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent cancer of the cervix.
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Detailed Description
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* Determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix 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 22-60 patients will be accrued for this study within 1-2 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
* 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:
* Monoclonal antibodies
* Cytokines
* Small-molecule inhibitors of signal transduction
* 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 for 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 for the malignant tumor
* No nonsteroidal anti-inflammatory drugs for 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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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Doctors Medical Center
Modesto, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Women's Cancer Center - Las Vegas
Las Vegas, Nevada, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Hope A Women's Cancer Center
Asheville, 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
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States
Williamette Gynecologic Oncology P.C.
Salem, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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LILLY-H3E-US-JMGS
Identifier Type: -
Identifier Source: secondary_id
GOG-0127T
Identifier Type: -
Identifier Source: org_study_id
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