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Tracking Information | |||||
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First Received Date ICMJE | July 8, 2004 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date ICMJE | May 2006 | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00087100 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer | ||||
Official Title ICMJE | A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma | ||||
Brief Summary | 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 persistent or recurrent endometrial cancer. |
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Detailed Description | 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 19-51 patients will be accrued for this study within 1-3.4 years. |
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Study Phase | Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Open Label | ||||
Condition ICMJE | Endometrial Cancer | ||||
Intervention ICMJE | Drug: pemetrexed disodium | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 51 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00087100 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000372921, GOG-0129O, LILLY-H3E-US-JMGT | ||||
Study Sponsor ICMJE | Gynecologic Oncology Group | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |