A Trial for Patients With Advanced/Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
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
  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:
  • LY231514
  • Alimta

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms by Site
Uterine Neoplasms
Urogenital Neoplasms
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 22, 2014