A Trial for Patients With Advanced/Recurrent Endometrial Cancer - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Gynecologic Oncology Group
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00377520

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 II

MedlinePlus related topics: Cancer Uterine Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacology toxicity [ Time Frame: every cycle ] [ 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
A: Experimental	Drug: pemetrexed 900 mg/m2, IV, q 21 days, until disease progression

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	8368, H3E-US-JMGT
Study First Received:	September 14, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00377520
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases

Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Recurrence
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009