A Trial for Patients With Advanced/Recurrent Endometrial Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00377520
First received: September 14, 2006
Last updated: November 13, 2009
Last verified: November 2009
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Purpose
The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Tumor Response [ Time Frame: baseline to measured progressive disease (up to 24 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With Adverse Events by Grade (Measures of Toxicity) [ Time Frame: every 21-day cycle (up to 24 months) ] [ Designated as safety issue: Yes ]
| Enrollment: | 27 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pemetrexed |
Drug: pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377520
Locations
| United States, Pennsylvania | |
| Gynecologic Oncology Group 215-854-0770 | |
| Philadelphia, Pennsylvania, United States, 19103 | |
Sponsors and Collaborators
Eli Lilly and Company
Gynecologic Oncology Group
Investigators
| Study Chair: | David Miller, MD | Gynecologic Oncology Group |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00377520 History of Changes |
| Other Study ID Numbers: | 8368, H3E-US-JMGT |
| Study First Received: | September 14, 2006 |
| Results First Received: | October 21, 2008 |
| Last Updated: | November 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Endometrial Neoplasms Sarcoma, Endometrial Stromal Genital Neoplasms, Female Neoplasms by Site Urogenital Neoplasms Uterine Neoplasms Adenoma Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma |
Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on June 18, 2013