A Trial for Patients With Gestational Trophoblastic Disease

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190918

Enrollment

Registered

2005-09-19

Start date

2006-07-31

Completion date

2007-07-31

Last updated

2007-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choriocarcinoma, Hydatidiform Mole, Trophoblastic Neoplasms, Uterine Neoplasms

Brief summary

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.

Interventions

DRUGPemetrexed

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026