Clinical trial NCT00377520: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
First posted: 2006-09-18
Enrollment: 27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tumor Response
timeFrame: baseline to measured progressive disease (up to 24 months)
Secondary outcomes:
measure: Number of Participants With Adverse Events by Grade (Measures of Toxicity)
timeFrame: every 21-day cycle (up to 24 months)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group 215-854-0770
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: David Miller, MD
role: STUDY_CHAIR
References: