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


Phase 2
N/A
N/A
Not Enrolling
Female
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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome Time Frame:

baseline to measured progressive disease (up to 24 months)

Safety Issue:

No

Principal Investigator

David Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

8368

NCT ID:

NCT00377520

Start Date:

September 2006

Completion Date:

September 2008

Related Keywords:

  • 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
  • Neoplasms
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Genital Neoplasms, Female
  • Neoplasms by Site
  • Urogenital Neoplasms
  • Uterine Neoplasms
  • Adenoma

Name

Location

Gynecologic Oncology Group 215-854-0770 Philadelphia, Pennsylvania