A Trial for Patients With Advanced/Recurrent Endometrial Cancer

NCT00377520 | Completed Phase 2 Results DMC

• 2 other identifiers: 8368H3E-US-JMGT
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to measured progressive disease (up to 24 months)

Secondary Outcomes (1)

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

  every 21-day cycle (up to 24 months)

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Drug: pemetrexed

Interventions

pemetrexed DRUG

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

Also known as: LY231514, Alimta

Pemetrexed

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have had prior therapy with Pemetrexed
• Patients who have received radiation to more than 25% of marrow bearing areas

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, 19103, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Female; Genital Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• David Miller, MD

  Gynecologic Oncology Group

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: September 1, 2008
• Last Updated: November 20, 2009
• Results First Posted: August 24, 2009

Record last verified: 2009-11

Locations

US (1)