A Trial for Patients With Gestational Trophoblastic Disease

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190918

Collaborator

Gynecologic Oncology Group (Other)

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trophoblastic Neoplasms Uterine Neoplasms Hydatidiform Mole Choriocarcinoma	Drug: Pemetrexed	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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