Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00190918
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00190918
Study Brief:
Protocol Section:
NCT00190918