Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT ID: NCT00087087
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
2004-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
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Detailed Description
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* Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer 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: A total of 19-51 patients will be accrued for this study within 11-22 months.
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
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN\*
* AST and ALT ≤ 3 times ULN\* NOTE: \* ≤ 5 times ULN if due to hepatic metastases
Renal
* Creatinine clearance ≥ 45 mL/min
Other
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No neuropathy (sensory or motor) \> grade 1
* No active infection requiring antibiotics
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following:
* Monoclonal antibodies
* Cytokines
* Small-molecule inhibitors of signal transduction
* At least 3 weeks since prior biologic or immunologic therapy
* At least 24 hours since prior growth factors
* No concurrent routine colony-stimulating factors
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
* 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
* No prior radiotherapy to \> 25% of bone marrow
* At least 2 weeks since prior radiotherapy and recovered
Surgery
* Recovered from prior surgery
Other
* No prior cancer treatment that would preclude study participation
* No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration
* Concurrent low-dose (≤ 325 mg/day) aspirin allowed
* At least 3 weeks since other prior therapy for the malignant tumor
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eli Lilly and Company
INDUSTRY
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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Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Women's Cancer Center - Las Vegas
Las Vegas, Nevada, United States
UMDNJ University Hospital
Newark, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Stony Brook University Cancer Center
Stony Brook, 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
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States
Williamette Gynecologic Oncology PC
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
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, 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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Other Identifiers
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LILLY-H3E-US-JMGP
Identifier Type: -
Identifier Source: secondary_id
CDR0000372919
Identifier Type: -
Identifier Source: secondary_id
GOG-0126Q
Identifier Type: -
Identifier Source: org_study_id
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