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A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Primary Purpose

Neoplasms, Neoplasms by Site, Urogenital Neoplasms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pemetrexed

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Gynecologic Oncology Group 215-854-0770

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed

Arm Description

Outcomes

Primary Outcome Measures

Tumor Response

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

Number of Participants With Adverse Events by Grade (Measures of Toxicity)

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.

Full Information

NCT ID

NCT00377520

First Posted

September 14, 2006

Last Updated

November 13, 2009

Sponsor

Eli Lilly and Company

Collaborators

Gynecologic Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT00377520

Brief Title

A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Official Title

A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

Gynecologic Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

900 mg/m2, intravenous (IV), every 21 days, until disease progression

Primary Outcome Measure Information:

Title

Tumor Response

Description

Time Frame

baseline to measured progressive disease (up to 24 months)

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events by Grade (Measures of Toxicity)

Description

Time Frame

every 21-day cycle (up to 24 months)

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Miller, MD

Organizational Affiliation

Gynecologic Oncology Group

Official's Role

Study Chair

Facility Information:

Facility Name

Gynecologic Oncology Group 215-854-0770

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Trial for Patients With Advanced/Recurrent Endometrial Cancer

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