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A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor


Phase 2
N/A
N/A
Not Enrolling
Female
Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole, Choriocarcinoma

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Trial Information

A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor


Inclusion Criteria:



- Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)

- WHO score 2-6 (re-evaluated at the time of relapse

- Histologically confirmed complete or partial moles on initial evacuation

- Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with
short elimination half-lives for a period of 2 days before, the day of, and 2 days
following administration of pemetrexed.

- All patients taking NSAIDs with longer half-lives, should interrupt dosing for at
least 5 days before, the day of, and 2 days following pemetrexed administration.

- Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days
prior to first dose of pemetrexed and continuing daily until 3 weeks after the last
dose of study therapy.

- Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection
approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated
approximately every 9 weeks until 3 weeks after the last dose of study therapy.

Exclusion Criteria:

- Previous treatment that included chemotherapy other than actinomycin -D or
methotrexate (+/- folinic acid).

- Patients with more than 8 metastatic lesions identified

- Patients with metastases to liver, spleen, brain, kidney or GI tract

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:

To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Principal Investigator

David Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

8366

NCT ID:

NCT00190918

Start Date:

July 2006

Completion Date:

July 2007

Related Keywords:

  • Trophoblastic Neoplasms
  • Uterine Neoplasms
  • Hydatidiform Mole
  • Choriocarcinoma
  • Neoplasms
  • Choriocarcinoma
  • Hydatidiform Mole
  • Trophoblastic Neoplasms
  • Uterine Neoplasms
  • Gestational Trophoblastic Neoplasms

Name

Location

Gynecologic Oncology Group 215-854-0770Philadelphia, Pennsylvania