A Trial for Patients With Advanced/Recurrent Cervical Cancer
NCT ID: NCT00190983
Last Updated: 2009-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2005-02-28
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemetrexed
Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
Interventions
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Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* Gynecologic Oncology Group (GOG) performance status 0-2
* Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
* Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs\_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
* All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
* Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
* Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy
Exclusion Criteria
* Patients who have received radiation to more than 25% of marrow bearing areas
* Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer
FEMALE
No
Sponsors
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Gynecologic Oncology Group
NETWORK
Eli Lilly and Company
INDUSTRY
Principal Investigators
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David Miller, MD
Role: STUDY_CHAIR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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H3E-US-JMGS
Identifier Type: -
Identifier Source: secondary_id
8367
Identifier Type: -
Identifier Source: org_study_id