A Trial for Patients With Advanced/Recurrent Endometrial Cancer
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ClinicalTrials.gov Identifier: NCT00377520 |
Recruitment Status :
Completed
First Posted : September 18, 2006
Results First Posted : August 24, 2009
Last Update Posted : November 20, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasms Neoplasms by Site Urogenital Neoplasms Genital Neoplasms, Female Uterine Neoplasms Endometrial Neoplasms Cancer of Endometrium Endometrial Cancer Cancer of the Endometrium Endometrium Cancer Neoplasms, Endometrial | Drug: pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed |
Drug: pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
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- Tumor Response [ Time Frame: baseline to measured progressive disease (up to 24 months) ]Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.
- Number of Participants With Adverse Events by Grade (Measures of Toxicity) [ Time Frame: every 21-day cycle (up to 24 months) ]Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have recurrent or persistent endometrial adenocarcinoma, which is refractory to curative therapy or established treatments.
- Patients must have measurable disease.
- Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma.
- Patients must have signed an approved informed consent.
- Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed.
- Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of the NSAIDs treatment.
- Patients must agree to this schedule in conjunction with every dose of Pemetrexed.
- Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting 7 days prior to the first treatment with Pemetrexed.
- Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after the last dose of Pemetrexed.
- Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed.
- Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed.
- Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed.
Exclusion Criteria:
- Patients who have had prior therapy with Pemetrexed
- Patients who have received radiation to more than 25% of marrow bearing areas

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377520
United States, Pennsylvania | |
Gynecologic Oncology Group 215-854-0770 | |
Philadelphia, Pennsylvania, United States, 19103 |
Study Chair: | David Miller, MD | Gynecologic Oncology Group |
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT00377520 |
Other Study ID Numbers: |
8368 H3E-US-JMGT |
First Posted: | September 18, 2006 Key Record Dates |
Results First Posted: | August 24, 2009 |
Last Update Posted: | November 20, 2009 |
Last Verified: | November 2009 |
Neoplasms Endometrial Neoplasms Neoplasms by Site Urogenital Neoplasms Uterine Neoplasms Genital Neoplasms, Female Uterine Diseases |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |