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A Trial for Patients With Advanced/Recurrent Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377520
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : August 24, 2009
Last Update Posted : November 20, 2009
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
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 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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemetrexed Drug: pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
  • LY231514
  • Alimta


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

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


Locations
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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
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Study Chair: David Miller, MD Gynecologic Oncology Group
More Information
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Additional Information:

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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
Additional relevant MeSH terms:
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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