Expired Study
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Philadelphia, Pennsylvania


Purpose:

This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.


Criteria:

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


NCT ID:

NCT00190918


Primary Contact:

Study Chair
David Miller, MD
Gynecologic Oncology Group


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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