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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087100 |
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.
Condition | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma |
Estimated Enrollment: | 51 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial adenocarcinoma
Measurable disease
Must have received 1 prior chemotherapy regimen for endometrial cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration
Study Chair: | David S. Miller, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000372921, GOG-0129O, LILLY-H3E-US-JMGT |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00087100 |
Health Authority: | United States: Federal Government |
recurrent endometrial carcinoma endometrial adenocarcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Folic Acid Pemetrexed Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases |
Uterine Neoplasms Urogenital Neoplasms Endometrial cancer Adenocarcinoma Recurrence Carcinoma |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |